7,442 Qa Validation jobs in the United States

**Specialist, QA Validation**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ** .
**The Role**
The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.
**Responsibilities**
+ Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
+ Provide QA review and approval for commissioning/qualification/validation documents.
+ Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
+ Work collaboratively with other site functions to instill a 'Quality Culture' by coaching in the application of GMP principles including the underlying rationale of those principles.
+ Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports.
+ Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed.
**Required Qualifications**
+ B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility.
+ Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
+ Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
+ Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
+ Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects.
+ Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
+ Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
+ Advanced computer skills.
+ Off hours coverage and flexibility may be required.
**Preferred Qualifications**
+ Experience with computer verification/validation.
+ Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product).
+ Experience working in a sterile fill/finish facility.
**Benefits**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
#LI-TD
Category BioPharma QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Sr. QA Validation Specialist as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity.

Key Responsibilities

• Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site
• Review and approve qualification/validation documentation (specifications, protocols, reports).
• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration)
• Provide expertise and solutions to issues regarding qualification and validation strategies and documentation
• Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems.
• Assist in the development of validation and qualification related policies, procedures, templates, forms
• Provides quality oversight on data integrity of systems, instruments, and equipment used at the site.
• Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.
• Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site
• Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Drive continuous improvement
• Other duties may be assigned, as necessary.

Requirements

• A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required.
• A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
• Experience in supporting cell-based products is a plus
• Strong knowledge of GxP compliance
• Experience in cGMP regulatory body audits
• Strong interpersonal and written/oral communication skills
• Ability to quickly process complex information and make critical decisions with limited information
• Ability to work independently and be responsible for a portfolio of ongoing projects
• Ability to pay attention to details and follow procedures closely
• Ability to identify and assess possible gaps and work collaboratively to address such issues
• Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
• Experience reviewing/auditing GMP documentation
• Strong proficiency with using Microsoft Office applications

#Li-DD1

#Li-Onsite

The anticipated base pay range is:

$107,482-$141,070 USD

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.

J oin Immatics and shape the future of cancer immunotherapy ; one patient at a time!

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.

Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.

Why Join Us?

• Innovative Environment: Help to pioneer advancements in cancer immunotherapy.
• Collaborative Culture: Be part of a diverse team dedicated to your professional growth.
• Global Impact: Contribute to therapies that make a lasting impact on patients globally.

We are seeking a Senior Quality Assurance Validation Specialist to support our Quality Assurance Validation team. The Senior Quality Assurance Validation Specialist will be a Subject Matter Expert in quality matters in the biopharmaceutical industry: this role serves as on-site QA representative in the U.S. based QA Validation team to handle commissioning, qualification and validation (CQV) activities. Specialist support covers multiple aspects in the Validation Lifecycle Management System (VLMS) from clinical phase toward commercialization including but not limited to quality oversight in equipment validation, analytical method validation and manufacturing process validation.

FLSA Classification : Salary/ Exempt
Schedule : 8:00 AM - 5:00 PM; Monday to Friday; On-site (Overtime hours on a business need basis)
Reports to : Manager, QA Validation
Location : 13203 Murphy Road Suite 100 Stafford, TX 77477

What You'll Do:

As a Senior Quality Assurance Validation Specialist, you will play a key role in supporting our validation operations:

• QA Review of validation documents including User Requirement Specifications, Design Verifications, Risk Assessments, Validation Plans, Qualification Protocols, Validation Reports.
• Quickly recognize, implement, and enforce compliance with applicable regulations,
• Propose best practices based on industry standards & guidance as well as state-of-the-art in the field of Cell Therapy (e.g. Adoptive Cell Therapy).
• Facilitate cross-functional teamwork with workstream's stakeholders including harmonization and alignment of own QA Validation deliverables with U.S. QA Validation Management, Global Quality Operations and cross-functional Leadership.
• QA review representative for pre- and post-execution deliverables of validation related documents which may focus on company's assets such as computerized systems, production process equipment, laboratory method studies, facilities and IT infrastructure in scope for GxP matters.
• Review Procedures such as Operational, Maintenance Cleaning documents (OMC) with focus on quality requirements and good documentation practices.
• Review deliverables from Quality Management Systems under VLMS, Change Control and Audits.
• Supports Project Management with Quality focus, Data Management, Digitalization initiatives, Business Continuity and Archival Business Processes.

Secondary Functions:

Secondary functions, ad-hoc or in case of need as directed by line manager, QA Validation:

• Support the Operational Quality Assurance Systems organization.
• Support Quality initiatives.
• Support Operational Excellence and Lean concepts

Required Experience and Education:

• At least 4 + years' experience in a related role
• Batchelor's degree in Computer Science, Life Sciences, or Engineering
• Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility).
• Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines.
• Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point.
• Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings.
• Advanced understanding of CQV and Lifecycle Pillars, which may include equipment/asset lifecycle management, equipment qualification execution, equipment operation, equipment maintenance, workflows incl. GxP Computerized System Validation (CSV), Qualification phases such as IQ, OQ, PQ, process validation, method validation and facility's commissioning & qualification.
• Intermediate to Advanced regulatory and auditing understanding.
• Intermediate to Advanced regulatory filing understanding with U.S. FDA such as Biologics License Application (BLA).
• Intermediate to Advanced project management or peer coaching/training experience showing organizational and interpersonal skills.
• Experience with cell-based production processes, cell-based and molecular-based analytical testing in the field of Cell and Gene Therapy including cell production, cell handling & maintenance, cell quantification, viral vector and nucleic acid quantitation or detection (e.g. based on Real Time PCR system).

Preferred Experience and Education:

• Experience in a wide variety of documents creation/contribution supporting qualification, validation, and release of pieces of equipment for quality control, or production (clinical and/or GMP commercial) within biopharma regulated settings.
• Experience in audit and inspections within regulated settings.
• Experience in Quality Assurance Release responsibilities within regulated settings.
• Experienced in Software application deployments and administration.
• Experience in analytical method validation.
• Experience in manufacturing process validation.
• Experience with IT infrastructure, computer/digital systems, and software solution deployments for biopharmaceutical business operations.
• Contributed to manufacturing site deployment activities in the biopharmaceutical industry.
• Experience in project management for operational excellence and lean concepts in the regulated pharmaceutical industry.

Competencies:

• Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines.
• Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point.

Work Environment:

• This position works in a typical office and/or lab and/or manufacturing clean room environment and/or other supporting facility areas with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis.

Travel required:

• Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility).

Physical demands:

• Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
• Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
• Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
• Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
• Pushing - Exerting force upon an object so that the object moves away from the object.
• Pulling - Exerting force upon an object so that the object moves toward the force.
• Sitting - remaining in a sitting position for at least 50% of the time.
• Standing/Walking - remain on one's feet in an upright position at a workstation.
• Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Work authorization/security clearance requirements :

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment

Affirmative Action/EEO statement:

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

What do we offer?

At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics

Comprehensive Benefits :

• Competitive rates for Health, Dental, and Vision Insurance

• 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
• Sick Time Off - 56 hours

• 12 Paid Holidays
• 100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K (club together)
• 100% Employer Paid Short- and Long-Term Disability Coverage
• 401(k) with Immediate Eligibility & company match.
  • You are eligible for 401(k) plan participation as of your first paycheck.
  • The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
• Partially paid Parental Leave for eligible employees. (3 weeks)

• Additional voluntary employee paid coverage including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.

Professional Growth :

• Opportunities to work with leading experts in the field of T-cell immunotherapy.
• Company provided learning and development opportunities

• Fast paced, high demand collaborative and dynamic environment.

QA Validation Fill Finish Team Hiring Manager!

As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

In this role, a typical day may include:

• Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices.
• Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation results.
• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports.
• Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs.
• Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Approves various documents relating to area function, including those listed above.
• Provide direction and assign work to Validations Specialists to meet goals and timings.
• Coordinates prioritization of activities with area management.
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
• Participates in regulatory and customer activities.
• Collaborates with functional departments to resolve issues.
• Leads projects and prepares status reports.

This role might be a fit for you if you:

• Have strong leadership and project management skills.
• Thrive in a quality focused environment.
• Possess a positive, proactive approach to drive projects/tasks to completion.
• Are able to mentor and encourage others.

Gowning and Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

To be considered for this role you must hold a Bachelor's degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level:

• Manager: 7 + years
• Sr. Manager: 8+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually): $104,300.00 - $199,000.00

Job Details

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and
procedures.

In this role, a typical day may include:

• Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices.
• Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation results.
• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports.
• Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs.
• Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Approves various documents relating to area function, including those listed above.
• Provide direction and assign work to Validations Specialists to meet goals and timings.
• Coordinates prioritization of activities with area management.
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
• Participates in regulatory and customer activities.
• Collaborates with functional departments to resolve issues.
• Leads projects and prepares status reports.

This role might be a fit for you if you:

• Have strong leadership and project management skills.
• Thrive in a quality focused environment.
• Possess a positive, proactive approach to drive projects/tasks to completion.
• Are able to mentor and encourage others.

Gowning and Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

To be considered for this role you must hold a Bachelors degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level:

• Associate Manager: 6+ years
• Manager: 7 + years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)
$89,100.00 - $170,100.00

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and

procedures.

In this role, a typical day may include:

• Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices.

• Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation results.

• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports.

• Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs.

• Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

• Approves various documents relating to area function, including those listed above.

• Provide direction and assign work to Validations Specialists to meet goals and timings.

• Coordinates prioritization of activities with area management.

• Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.

• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.

• Participates in regulatory and customer activities.

• Collaborates with functional departments to resolve issues.

• Leads projects and prepares status reports.

This role might be a fit for you if you:

• Have strong leadership and project management skills.

• Thrive in a quality focused environment.

• Possess a positive, proactive approach to drive projects/tasks to completion.

• Are able to mentor and encourage others.

Gowning and Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

To be considered for this role you must hold a Bachelor's degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level:

• Associate Manager: 6+ years

• Manager: 7 + years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$89,100.00 - $170,100.00

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and
procedures.
In this role, a typical day may include:
+ Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices.
+ Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation results.
+ Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports.
+ Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs.
+ Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
+ Approves various documents relating to area function, including those listed above.
+ Provide direction and assign work to Validations Specialists to meet goals and timings.
+ Coordinates prioritization of activities with area management.
+ Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
+ Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
+ Participates in regulatory and customer activities.
+ Collaborates with functional departments to resolve issues.
+ Leads projects and prepares status reports.
This role might be a fit for you if you:
+ Have strong leadership and project management skills.
+ Thrive in a quality focused environment.
+ Possess a positive, proactive approach to drive projects/tasks to completion.
+ Are able to mentor and encourage others.
Gowning and Environment
+ Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
+ Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for this role you must hold a Bachelor's degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level:
+ Associate Manager: 6+ years
+ Manager: 7 + years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$89,100.00 - $170,100.00

Senior QA Validation Specialist - CSV Systems Engineer
Summary:
The Senior Validation Specialist, assists with the validation activities throughout the plant, coordinates appropriate support and assists in completing validation activities and provides technical assistance to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues. This role serves as a source of expertise in the group for validating new systems and processes.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.
We proudly offer
+ Generous benefit options
+ Paid training, vacation and holidays
+ Career advancement opportunities
+ Education reimbursement
+ 401k program
+ And more!
Supervisory responsibilities
This position does not have supervisory responsibilities.
Essential job duties
+ Provide quality review and approval of validation activities associated with changes to existing systems and projects that support the site
+ Support protocol development and approval, investigations for deviations and champion local, corporate and regulatory standards
+ Present and support validation concepts and approaches with audits and inspections
+ Provide Quality validation review and approval through the preparation, execution, data analysis, and report writing for IQ, OQ and PQ protocols
+ Quality review and approval of Change Requests (CR's) related to project validation and other validation activities for the site
+ Perform compliance and technical reviews/approvals of protocols and protocol data
+ Review and approve validation failure investigations and non-conformities utilizing root cause analysis techniques
+ Review and approve specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes and the validation
+ Identify process improvements before equipment, systems or processes are placed under change control during validation
+ Manage and complete each assigned Annual Product Review (APR). This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures
+ Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, as well as applicable project teams
+ Track all validation documentation throughout the plant and follow-up as needed
+ Exhibit safety awareness and safe work practices
Education, experience, certification and licensures Required
·BA/BS Degree in Chemistry, Engineering or a relevant field and 8 years of related work experience in validation/quality related discipline or drug development
OR
·MA/MS Degree in Chemistry, Engineering or a relevant field and 6 years of related work experience in validation/quality related discipline or drug development
OR
·PhD in Chemistry, Engineering or a relevant field and 4 years of related work experience in validation/quality related discipline or drug development
Preferred
· Leadership experience
Knowledge, skills and abilities
+ Expert in quality concepts including technical and compliance review of documents
+ Expert competence in one or more core validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation)
+ Expert in cGMP documentation practices
Physical requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Work environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one's environment and taking proper precautions is required). The noise level in the work environment is usually moderate.
Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.
Pay Range: $90,000 - 112,400
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
#LI-DR1

Job Details

Our Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY.

• Equipment Includes: Syringe and Vial Fillers, Lyophilizer, Semi-Automatic and Automatic Inspection, Assembly Machines, Packaging Machines, Serialization, Case Packer and Palletizer

In this role, a typical day might include the following:

• Monitor compliance, analyze failures, and assess corrective actions.

• Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control)

• Must be able to present in a pressure test scenario the technical area they are SME for

• Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends.

• Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

• Reviews, edits and approves change controls, SOPs, reports and other documentation

• Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Collaborates with functional departments to resolve issues.

• Trains/advises less experienced Specialists.

• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.

• Manage and drives projects and prepares status reports.

• May present at both internal and external (regulatory) audits.

• May manage full time employees and/or contingent workers.

• Performs other duties assigned by Management.

This role may be for you if you:

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Gathers and organizes information

• Effective time management skills

• Seeks to identify continuous improvement needs

Gowning and Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and the following years experience for each level:

• QA Validation Specialist: 2+ years
• Sr QA Validation Specialist: 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)
$66,400.00 - $126,800.00