4,168 Qa Validation jobs in the United States

**Specialist, QA Validation (Onsite in Sanford, NC)**
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**
This is an **Onsite** role in **Sanford, NC** . The **Specialist, QA Validation** is responsible for providing quality assurance oversight and support for the commissioning, qualification, and validation (CQV) activities across the site. This role ensures that all validation efforts comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. The position collaborates cross-functionally with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.
**Responsibilities**
+ Provide QA oversight and support for CQV activities including but not limited to equipment, instruments, utilities, clean rooms, computer systems, and manufacturing process.
+ Evaluate and approve qualification/validation discrepancies and corrective/preventative actions (CAPAs).
+ Provide QA oversight periodic review and lifecycle management activities for validated systems and computerized systems.Support revalidation as required by lifecycle management or change control.
+ Review and approve change management documentation including Engineering Change Management, Automation Change Management, and general Change Controls.
+ Promote and maintain a strong cGMP quality culture across the organization.
+ Ensure adherence to local and global quality standards, regulatory requirements, and industry best practices.
+ Participate in internal and external audits, including regulatory inspections (e.g., FDA, EMA, DHHS) and third-party or corporate partner audits.
**Required Qualifications**
+ Bachelor's degree in a related scientific or technical discipline with3-5+ years of experience in biotechnology or pharmaceutical industryor a Master's degree and 1-3+ years of experience in biotechnology or pharmaceutical industry.
+ Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
+ Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
+ Working knowledge of FDA and EMAregulations 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 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

**About the role**
As a **Senior QA Validation Analyst** , you will make an impact by leading the testing and validation strategy for Electronic Lab Notebook (ELN) systems and their integration platforms. You will be a valued member of the Life Sciences team and work collaboratively with cross-functional stakeholders including QA, IT, and business partners across geographies.
**In this role, you will:**
+ Lead the validation and testing strategy for ELN systems, ensuring robust and efficient processes.
+ Oversee testing activities to guarantee seamless integration across platforms.
+ Utilize ALM tools (e.g., HP ALM, JIRA) to manage and streamline testing workflows.
+ Collaborate with R&D teams to align testing efforts with project goals.
+ Develop and execute comprehensive test plans and cases covering all functional requirements.
+ Monitor testing progress, report outcomes, and address issues proactively.
+ Ensure adherence to company policies and industry best practices.
+ Mentor junior testers and foster a culture of continuous improvement.
+ Analyze test results to provide actionable insights for product enhancements.
+ Communicate testing outcomes and recommendations to stakeholders.
+ Drive innovation in testing methodologies to improve efficiency and effectiveness.
**Work model:**
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role's business requirements, this is a **hybrid position requiring 2-3 days a week** in a client or Cognizant office in **Boston, MA** . Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
**What you need to have to be considered:**
+ Proven expertise in managing the full testing lifecycle: URS, Risk Assessment, System Testing, Integration Testing, UAT, Traceability Matrix, and Test Summary Reports.
+ Strong documentation and audit readiness skills, including authoring and reviewing test plans and traceability matrices.
+ Experience in the pharmaceutical or life sciences domain.
+ Hands-on experience with ELN systems and integration platforms; familiarity with Benchling is a plus.
+ Ability to lead cross-functional teams and coordinate across QA, IT, and business stakeholders.
+ Skilled in managing testing deliverables across geographies and time zones.
+ Familiarity with Agile, Waterfall, and V-Model SDLC approaches.
+ Proficiency in tools such as HP ALM, JIRA, ServiceNow, and SharePoint.
+ Strong communication skills and stakeholder engagement capabilities.
+ Proactive approach to problem-solving and process improvement.
+ Commitment to continuous learning and professional development.
**These will help you stand out:**
+ Experience with data validation, integration testing, and analytics platforms.
+ Thought leadership in testing innovation and methodology improvements.
+ Ability to translate test outcomes into strategic recommendations for product enhancement.
+ Demonstrated success in mentoring and developing testing talent.
+ Familiarity with regulatory compliance and audit processes in life sciences.
+ Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
**·** **_Salary and Other Compensation:_**
· The annual salary for this position is between ($53,477/- to $92,500/-) depending on experience and other qualifications of the successful candidate.
· This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
**·** **_Benefits:_**
· Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
· Medical/Dental/Vision/Life Insurance
· Paid holidays plus Paid Time Off
· 401(k) plan and contributions
· Long-term/Short-term Disability
· Paid Parental Leave
Employee Stock Purchase Plan
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

**Use Your Power for Purpose**
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
**What You Will Achieve**
In this role, you will:
+ Review validation documentation for the site, (including but not limited to change controls, cleaning, process, equipment, laboratory validation, data records, SOPs, automation and maintenance document, and technical reports associated with clinical and commercial processing) ensuring adherence to regulatory agency requirements, ICH Guidelines, and Pfizer standards, policies and values
+ Plan and execute projects with support; suggest improvements and conducts continuous improvement activities
+ Represent QA Validation in cross-departmental/cross-site meetings
+ Maintain oversight of quality and compliance requirements throughout the product life cycle from design through BLA submission
+ Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
+ Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
+ Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
+ Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
+ Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.
**Here Is What You Need** (Minimum Requirements)
+ Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years of experience; or an Associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience.
+ Proven expertise in current Good Manufacturing Practices and relevant GxP regulations and standards.
+ Experience with regulatory compliance and documentation
+ Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
+ Strong working knowledge in Microsoft Office Suite
**Bonus Points If You Have** (Preferred Requirements)
+ Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
+ Experience in regulatory audits and compliance
+ Experience with sterile products and medical devices
**Physical/Mental Requirements**
+ Excellent verbal and written communication skills
+ Ability to work independently and in a team environment
+ Strong analytical and problem-solving skills
+ Strong organizational and time management skills
+ Ability to mentor and guide other colleagues
**Non-Standard Work Schedule, Travel, or Environment Requirements**
+ This role is standard day Monday through Friday work shift.
**Other Job Details:**
+ Last day to Apply: October 13th, 2025
+ Eligible for Relocation Assistance: No
+ Work Location Assignment: On Premise
The annual base salary for this position ranges from $80 300,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10,0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
**Sunshine Act**
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
**EEO & Employment Eligibility**
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Quality Assurance and Control

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

Our QA Fill Finish Validation team is hiring a Principal QA Validation Specialist to validate and qualify equipment, systems, and processes in compliance with regulatory standards. Support our newly constricted Fill Finish Facility in Upstate NY and contribute to a fast-paced, innovative environment.
In this role, a typical day might include the following:
+ Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ).
+ Act as a Technical SME (Subject Matter Expert) in areas including Equipment Qualification, Drug Product Filling Validation, and Automated/Semi-Automated Visual Inspection.
+ Validate equipment such as Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems.
+ Must be able to present in a "pressure test" scenario the technical area they are SME for.
+ Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls.
+ Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
+ May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
+ May present at both internal and external (regulatory) audits.
This role may be for you if you:
+ Have expertise in validation processes including automated/semi-automated visual inspection and finished goods handling.
+ Ability to communicate with transparency.
+ Continuously aim to improve processes for improved performance.
+ Have strong communication, time management, and problem-solving skills.
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
+ Principal QA Validation Specialist: 8+ 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 - $148,400.00

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

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 Description
Insight Global is seeking a Test Automation Test Lead. This resource will join as an Automation Engineer Lead for a forward-thinking team. In this role, you will be responsible for designing, developing, and implementing frameworks that ensure the quality and reliability of our software products. You will collaborate closely with cross-functional teams, including developers, product managers, data engineers and test analysis, to identify testing requirements and integrate automation seamlessly into our testing processes. In this key role, you will be at the forefront of our vision, responsible for implementing automated testing frameworks to the embedded scrum level engineers. Your expertise will ensure that our software not only meets but exceed the highest standards of quality and performance. This opportunity will include data generation, testing automation/AI, best practices and End to End services.
Responsibilities:
- Design, develop, and implement automation frameworks to ensure software quality and reliability
- Collaborate with developers, product managers, data engineers, and test analysts to define testing requirements
- Integrate automation seamlessly into the testing process at the embedded scrum level
- Lead the implementation of automated testing frameworks
- Drive initiatives in data generation, AI-driven testing automation, and end-to-end service validation
This role will be instrumental in helping this client:
- Increase Quality and reduce production defects
- Expand testing coverage and accelerate testing cycles
- Introduce testing methods and best practices
- Find efficiencies and reduce cost
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- Experience with Medicare or Government Programs
- Proven ability to develop best practices, maturity models, and manage defects in automated testing and AI initiatives
- Hands-on experience with Selenium and other automation tools
- Proficiency in automation frameworks, Automation Anywhere, and automated BOTs
- Experience with Artificial Intelligence (AI) technologies
- Familiarity with Open Language tools and SQL
- Strong analytical skills with the ability to design and implement comprehensive testing strategies
- Ability to collaborate with cross-functional teams to identify risks and develop mitigation plans
- A proactive mindset to anticipate challenges and drive continuous improvement
- Excellent communication skills, with the ability to translate complex technical concepts into actionable insights
- Demonstrated leadership in automation strategy and execution for complex projects, ensuring full test coverage
- Experience in optimizing and improving existing automation processes and frameworks
- Proven ability to mentor and guide automation engineers, fostering a culture of continuous learning