6,168 Process Validation jobs in the United States
Sr. Validation Engineer, Process Validation
Posted 15 days ago
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Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Aldevron, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to life-impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential-one discovery at a time.
Learn about the Danaher Business System ( which makes everything possible.
The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND site. As the subject matter expert in validation, this position leads the development, execution, and implementation of validation, practices, policy, and procedures.
This position reports to the VP, Global Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role.
In this role, you will have the opportunity to:
+ Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product
+ Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design
+ Develop and implement validation policies and procedures based on current regulations and industry standards
+ Provide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing support
+ Help resolve quality issues and CAPA's leading lab investigations, risk assessments, root cause analysis, and developing implementation plans
The essential requirements of the job include:
+ Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) with 5+ years of experience or MS degree with 3+ years of experience.
+ PhD in Engineering or Scientific field with 2+ years of experience.
+ Experience in process development, engineering, and process validation required. Experience working in CDMO environment is a plus
+ Experience using statistical, risk assessment, and process improvement tools
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
+ 10% travel to support routine inspections, audits, and customer projects
It would be a plus if you also possess previous experience in:
+ Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
#LI-KP1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1- or .
Engineer II, Process Validation
Posted 15 days ago
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Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
The Process Validation Engineer II is part of the Technical Operations Department located in Fargo, ND and will be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external validation projects.
In this role, you will have the opportunity to:
+ Develop and review validation documents for facilities, equipment, and processes.
+ Ensure all documents comply with corporate standards and regulatory requirements.
+ Collaborate on experiments for new or modified manufacturing processes and equipment.
+ Analyze critical data and provide informed recommendations.
+ Support all phases of the validation life cycle, including research, development, and continuous monitoring.
The essential requirements of the job include:
+ Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) and 4+ years of experience in process development and/or technology transfer OR Associate degree in Engineering Technology or related field with 6+ years of process development experience in a life sciences company
+ Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
It would be a plus if you also possess previous experience in:
+ Authoring, executing, and summarizing process validation lifecycle documents for stages 1, 2, and 3.
+ Technical writing involving quality investigations, root cause analysis, and risk assessment.
#LI-KP1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1- or .
Process Validation Consultant
Posted today
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Job Description
LOCATION: Gurabo / Juncos / Las Piedras
We are seeking an experienced Process Validation Consultant to support a pharmaceutical manufacturing facility in the central/ East area of Puerto Rico. The consultant will lead and execute validation activities for new and existing processes in compliance with FDA, EU, and other international regulations. This is a contract-based opportunity for an independent professional with expertise in process validation, cGMP requirements, and technology transfer within pharmaceutical and consumer health operations.
Main responsibilities:
- Develop and execute process validation protocols (IQ/OQ/PQ) for manufacturing and packaging processes.
- Create and review validation master plans, risk assessments, and validation summary reports.
- Support process scale up for new or reformulated products.
- Ensure validated processes meet cGMP and regulatory standards (FDA, EU, ICH).
- Collaborate with engineering, quality assurance, manufacturing, and regulatory teams to optimize process performance and resolve deviations.
- Prepare summary reports.
- Implement and oversee continued process verification (CPV) to maintain process control post qualification.
- Review and manage validation related deviations, change controls, and CAPA activities.
- Support cleaning validation and equipment/utilities qualification as applicable.
- Other related activities.
General requirements:
- Fluency in Spanish and English (spoken and written)
- Strong technical writing and documentation skills.
- Ability to work independently and manage multiple priorities.
- Proficiency in Microsoft Office 365 (Excel, Word, Power Point) and project management tools.
- Organizational skills, attention to detail, and ability to manage multiple tasks.
- Excellent communication skills.
Education Requirements:
- Minimum: Bachelor's degree in engineering, Life Sciences, Chemistry, Biology, or related field.
- A combination of education and relevant experience can be considered.
Experience Requirements:
- 5+ years of experience in process validation within pharmaceutical or consumer health manufacturing.
- Proven knowledge of cGMP, FDA, ICH, and other regulatory requirements and guidance.
Physical requirements
- Ability to sit for long periods of time.
- Light physical activity may be required occasionally.
- You should be able to visit field locations as needed.
- Must be able to use personal protective equipment (PPE) when required.
- Ability to perform in diverse industrial environments.
Principal Process Controls & Validation Engineer
Posted 24 days ago
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As a Principal/Staff Process Controls & Validation Engineer **,** a typical day might include the following:
+ Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
+ Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
+ Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history.
+ Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
+ Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
+ Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
+ Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.
+ Applies engineering principles to the development and execution of process controls and validation strategies.
+ Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
+ Develops and monitors health of the business using key performance indicators.
+ Develops and improves cross-functional business and manufacturing processes.
+ Works effectively and efficiently in a team-oriented environment.
+ Provides support to laboratory studies and/or studies performed at manufacturing scale.
This role might be for you if you:
+ Can perform advanced problem solving including addressing ambiguous issues and situations.
+ Can accurately scope projects - break down work into process steps, develop schedules and tasks, identify, interpret, and communicate risk (process management, measuring & managing work).
+ Can deal with changing priorities and are able to adapt to change.
+ Can use technical expertise to influence a non-technical audience on a path forward.
To be considered for Principal Process Controls & Validation Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Engineering; Biomedical engineering, Chemical Engineering preferred. For various levels you must have the following:
+ Principal Process Controls & Validation Engineer: 8+ years in Drug Product/Labeled Drug Product
+ Staff Process Controls & Validation Engineer 10+ years in Drug Product/Labeled Drug Product
+ Or equivalent combination of education& experience in Drug Product/Labeled Drug Product
Experience in aseptic processing, drug product development, labeled drug product processing, or biopharmaceutical/combination product validation is required.
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)**
$90,800.00 - $173,400.00
Associate Director, Process Validation
Posted today
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About Affinivax Affinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next-generation approach to the development of vaccines and immunotherapies targeting infectious and other immune-mediated diseases. This novel and high Director, Validation, Associate, Process, Operations, Monitoring
Director, Process Validation & Risk Management
Posted today
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Director, Process Validation & Risk Management Join to apply for the Director, Process Validation & Risk Management role at Vaxcyte Director, Process Validation & Risk Management 2 days ago Be among the first 25 applicants Join to apply for the Director, Process Validation & Risk Management role at Vaxcyte Get AI-powered advice on this job and more exclusive features. Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT We Do Is Every Bit As Important As HOW We Do It! Our Work Together Is Guided By Four Enduring Core Values RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary The Director, Process Validation and Risk Management has the accountability for: Commercial process validation of the Vaxcyte end -to-end processes Identification, assessment, and mitigation of operational, technical, and regulatory risks within the end-to-end manufacturing processes Role In this role the Director will be a part of the Global MSAT organization reporting to the Sr. Director of Process Validation. This role will be immersed in all aspects of operations in a commercial setting, which includes: Development of Process Validation/Process Performance Qualification/CPV strategy for the life cycle of products, ensuring alignment with regulatory guidelines and industry standards. Apply a fundamental understanding of bioprocessing to support continuous process validation for commercial processes, new site/plant start-up, execution of validation projects and/or protocols and the collection of data to support completion of process validation activities. Provide guidance for the generation, resolution and closure of deviations and ensure safety and compliance of validation activities including support for regulatory filing, inspection, and other CMC and technology team activities. Influence engineering, facility, systems and method validations within the commercial organization. Lead the development and execution of risk assessments to identify potential risks and plan mitigation strategies to sustain processes in a state of inspection and regulatory compliance readiness Collaborate with business units and other stakeholders to ensure that operational risks are effectively managed and mitigated. Monitor and report on key risk indicators and risk events, providing regular updates to senior management. Ensure compliance with regulatory requirements and industry best practices related to operational risk management. Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, commercial process validation, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Raw Materials, Polysaccharides, Carrier Proteins, Conjugation across all DS production and formulation, fill finish and packaging across all DP production. Essential Functions Raw Material Qualification – Provide guidance and establish principles for complex and critical raw material qualification with internal and external stakeholders to ensure consistent and reliable supply to the commercial processes. DS Validation – Provide strategic and scientific leadership for process verification and validation with internal and external stakeholders and ensure successful execution of launch plans and post launch commercial activities. Risk management - Develop and implement a risk management framework, collaborating with Quality on developing policies, procedures and tools for identifying, assessing, monitoring, and reporting risks. Interface - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful commercialization of pipeline products. Support technical services - Support of our internal and external manufacturing network validations, including qualification of raw materials. Process validation and comparability - Provide support for the execution of process validation and process comparability activities. Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for validation to the Boards of Health for regulatory submissions for commercialization. Communicate - Effectively and efficiently communicate process validation performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. Executing for Results - Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and move forward through complex situations. Leadership – Provide technical leadership and contribute as a member of the Global MSAT organization, with an aim to ensure effective and efficient delivery of our life enhancing therapies to our patients. Travel - 10-30% domestic and international travel required. Requirements Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, Biotechnology or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A. or 16+ years for B.S./B.A. Protein synthesis process experience preferred with a background of process and support system validation, MSAT/Technical Operations/Late phase process development/Commercialization. Broad experience in understanding aspects of process characterization, product development, multivalent vaccines, and relevant fill finish unit operations across multiple operational scales. Technical leadership experience in Process or Product validation strategy supporting technology transfer, project management and regulatory documentation. Experience in quality risk management and ICH Q9; strong knowledge of quality risk management frameworks, methodologies, and regulatory requirements. Ability to develop a full and deep understanding of the operational, technical and quality operations, both internally and externally, and how they create value and risk for the overall organization Excellent organization, problem solving and strategic planning skills. Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives. Proactively recognizes needs and potential challenges and collaborates to implement effective solutions. The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization’s overall strategy. An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry. Reports to: Sr. Director, Process Validation Location: San Carlos, CA Compensation The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $208,000 – $43,000 (SF Bay Area). Salary ranges for non-California locations may vary. Relocation: This role is not eligible for relocation assistance. We are 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, disability or veteran status. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Finance and Sales Referrals increase your chances of interviewing at Vaxcyte by 2x Get notified about new Director of Risk Management jobs in San Carlos, CA . 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Oracle Finance Systems Testing & Process Validation - Manager / Sr Manager
Posted 7 days ago
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The Opportunity:
The Oracle Finance Systems Testing Manager/Sr Manager will have an important role in managing the Oracle end-to-end business and 3rd party integrations testing activities for three testing cycles and post go live for the NextGen Finance program. He/she will work closely with 15 workstream leads, the Systems Implementation test lead, the IT test lead, and the NextGen Finance Program Manager to execute against the testing strategy. The NextGen Finance program aims to modernize the global finance function and streamline work across the organization by transitioning to the Oracle Fusion cloud financials solution which includes 24 conversions from 10 sources and 200+ integrations to ~45 internal and external systems and partners. Mattel operates in 35 countries and sell products in >150 countries.
To excel in this role, the candidate should have a solid background of end-to-end systems testing methodologies, processes, and tools in Oracle Fusion cloud for financials, as well as excellent communication skills. Experience in large, global system implementations, systems integrations testing, user acceptance testing, and a good understanding of Finance functions will be important. Experience with testing Oracle integrations with Coupa, Workday and/or High Radius is a plus.
What Your Impact Will Be:
* Assist and work alongside the workstream leads to Drive "end-to-end" process management and governance for enterprise wide processes (e.g., P2P, O2C, R2R, A2R)
* Assist and work alongside the workstream leads to Develop the vision and strategy for each of the respective end-to-end processes
* Manage the end-to-end test planning and execution of three test cycles across Oracle Fusion cloud for financials and many 3rd party systems for all financial processes based on the testing strategy. Go live planned for summer of 2024.
* Have a good understanding of Finance business functions in order to make sound resourcing decisions e.g. Accounts Receivables, Accounts Payables, General Ledger, Financial Planning, Controllership, and end-to-end processes like Order to Cash, Record to Report, Plan to Perform.
* Collaborate with Systems Implementation Partner test lead and IT test lead to develop and implement the overall Systems Integrations (CRP2) test plan and UAT test plan, in alignment with testing strategy, project objectives, and timelines.
* Collaborate with business stakeholders to identify and define UAT scope, objectives, and success criteria.
* Collaborate with Workstream leads to review identified test scenarios and scripts for end-to-end testing including 3rd party systems.
* Work with Workstream leads to coordinate testers and align resources to end to end test scenarios
* Provide guidance and support to the CRP2 and UAT team throughout the testing lifecycle, including test case creation, execution, and defect management.
* Establish and maintain effective communication channels with project stakeholders to provide regular updates on CRP2 and UAT progress, issues, and risks.
* Monitor and track CRP2 and UAT metrics, such as test coverage, defect density, and defect closure rates, to assess the quality of the tested systems.
* Work with Workstream leads, IT and Implementation partner to align data sets to test scenarios that initiate in 3rd parties e.g. Coupa
* Modify scripts and scenarios based on feedback and outcomes of prior test cycles
* Collaborate with development and quality assurance teams to investigate and resolve UAT-related issues and defects.
* Collaborate with Systems Implementation Partner on review of testing results, proposed re-testing required and prioritization of failed test scripts
* Facilitate discussions with internal audit to share test results and outcomes. Systems Implementation Partner to support discussions.
* Conduct post-implementation reviews to gather feedback and identify areas for improvement in future testing cycles.
* Manage a high degree of change in a fast paced, complex, and demanding environment.
* Lead and direct work of others who do not directly report to you but whose input and cooperation is needed on the project.
What We're Looking For:
* Demonstrated success in managing large, global systems integrations and UAT testing cycles in Oracle Fusion cloud for financials
* Proficiency in test management tools, defect tracking systems, and collaboration platforms.
* Experience with Finance business functions e.g. Accounts Receivables, Accounts Payables, General Ledger, Financial Planning, Controllership, and end-to-end processes like Order to Cash, Record to Report, Plan to Perform.
* Experience with large, global system implementations with globally disbursed project resources
* Experience with Coupa, Workday, and/or High Radius a plus
* Leadership qualities including strategic and critical thinking, relationship management, organizational skills and ability to motivate and influence others
* Successful track record working with business teams to define, develop, test and launch new processes and new programs
* Excellent communication (verbal and written) & presentation skills, including ability to tailor communication to audience to achieve desired results
* Ability to anticipate potential issues and propose mitigation plans
* Innate capability to create order out of chaos
* Ability to plan, organize and proctor efficient meetings through preparation, stakeholder buy in, and guide a group towards agreed upon objectives
* Experience with analyzing complex issues and delivering appropriate solutions
* Demonstrated ability to think out of the box and generate creative solutions
* Demonstrated a growth mindset by staying curious and continuously learning, embracing challenges, and improving themselves.
The annual base salary range for this position is between $124,000 and 180,000
This range is indicative of projected hiring range, however annual base salary will be determined based on a candidate's work location, skills and experience. Mattel offers competitive total pay programs, comprehensive benefits, and resources to help empower a culture where every employee can reach their full potential.
Don't meet every single requirement? At Mattel, we are dedicated to an inclusive workplace and a culture of belonging. If you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we still encourage you to apply. You may be just the right candidate for this or other roles.
How We Work:
We are a purpose driven company aiming to empower generations to explore the wonder of childhood and reach their full potential. We live up to our purpose employing the following behaviors:
* We collaborate: Being a part of Mattel means being part of one team with shared values and common goals. Every person counts and working closely together always brings better results. Partnership is our process and our collective capabilities is our superpower.
* We innovate: At Mattel we always aim to find new and better ways to create innovative products and experiences. No matter where you work in the organization, you can always make a difference and have real impact. We welcome new ideas and value new initiatives that challenge conventional thinking.
* We execute: We are a performance-driven company. We strive for excellence and are focused on pursuing best-in-class outcomes. We believe in accountability and ownership and know that our people are at their best when they are empowered to create and deliver results.
Who We Are:
Mattel is a leading global toy and family entertainment company and owner of one of the most iconic brand portfolios in the world. We engage consumers and fans through our franchise brands, including Barbie, Hot Wheels, Fisher-Price, American Girl, Thomas & Friends, UNO, Masters of the Universe, Matchbox, Monster High, MEGA and Polly Pocket, as well as other popular properties that we own or license in partnership with global entertainment companies. Our offerings include toys, content, consumer products, digital and live experiences. Our products are sold in collaboration with the world's leading retail and ecommerce companies. Since its founding in 1945, Mattel is proud to be a trusted partner in empowering generations to explore the wonder of childhood and reach their full potential.
Mattel's award-winning workplace culture has been recognized by Forbes, Fast Company, Newsweek, Great Place to Work, TIME, and more.
Visit us at and is an Equal Opportunity Employer where we want you to bring your authentic self to work every day. We welcome all job seekers, and all applicants will receive consideration for employment without regard to race, ethnicity, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, veteran and protected veteran status, disability status, and or any other basis protected by applicable federal, state or local law.
Pursuant to the Los Angeles Fair Chance Ordinance and the California Fair Chance Act, qualified applicants with arrest or conviction records will be considered for employment.
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Validation Engineer
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Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer.
This position, in the Manufacturing and Formulations Services department, requires a Bachelor s degree or higher in a scientific or engineering discipline with either 3 years of experience or an equivalent combination of education and experience in a GMP laboratory or manufacturing environment. Special consideration given to candidates with experience with automated filling equipment especially in a sterile manufacturing environment.
Responsibilities include: create and execute equipment installation and operational qualification/requalification, calibration, and preventative maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications /develop Standard Operating Procedures and training materials for manufacturing equipment / perform Factory Acceptance Tests for new equipment at vendor sites/monitor ViewLinc and respond to excursions as needed/perform data trending and write reports, change requests, and deviations / communicate with clients, manufacturing and formulations management, and the quality group.
Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.
QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility.
QCL is an equal opportunity employer.
Validation Engineer
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The Validation Engineer will report to the Sustaining Engineering Manager and will focus on life cycle management for the Medical Division's existing products. This position will evaluate manufacturing processes and perform validation tests to ensure compliance with company requirements and industry standards.
This is a highly strategic role within the ITW Medical business and provides a path for driving meaningful impact within the business.
**Roles and Responsibilities**
+ Develops and executes validation protocols (IQ, OQ, PQ) for equipment, processes, and products.
+ Establishes validation standards and develops performance testing and quality control measures. Develop test procedures that produces validation data.
+ Analyzes and interprets validation data to identify trends, anomalies, and areas for improvement, utilizing statistical techniques.
+ Ensures validation activities comply with regulatory requirements and industry standards.
+ Independently tests, analyzes and solves technical problems.
+ Performs risk assessments and develops mitigation strategies related to validation activities.
+ Works with customers to understand requirements and translates into validation protocols and specifications. Reviews and approves validation deliverables from customers and third-party service providers.
+ Conducts FMEAs and risk analysis as a part of the design control process.
+ Identifies root causes of production problems. Identifies nonconformities of product or process standards and offers recommendations for resolving deviations.
+ Provides technical support to the production team on product specifications and requirements.
+ Works closely with Engineers, Customers, Sales and Manufacturing regarding engineering change management.
**Qualifications**
+ Minimum of 5+ years injection molding in a high-volume manufacturing environment required, preferably in medical-device manufacturing.
+ Bachelor's degrees in engineering or related field required.
+ Demonstrates comprehensive knowledge of Engineering & Statistical principles and their application in solving complex problems.
+ In-depth knowledge of production processes, parameters, and standards.
+ Possesses an understanding of DFMEA & PFMEA methodology and approach, understands part design layout and GD&T.
+ Excellent leadership, collaboration, and both written and verbal communication skills.
+ Team-oriented individual who thrives in a fast-paced environment.
+ Possess the ability to train, mentor and coach others to solve technical problems.
**Physical Demands:**
+ While performing the duties of this job, the employee is regularly required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is frequently required to reach with hands and arms, stoop, kneel, or crawl; and talk or hear.
+ The employee must frequently lift and move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
**Compensation Information:**
Pay Transparency
This compensation range is provided as a reasonable estimate of the current salary range for this role. Compensation depends on relevant experience and/or education, specific skills, market level, other job-related factors, geographic location, and other factors as applicable by law. As applicable this role will also receive overtime compensation and may be eligible for shift premium compensation.
Pay Range:$85,000-110,000
Benefits
Benefits for this role can be seen by visiting In addition, employees can qualify for vacation, sick, and holiday compensation benefits.
Vacation - up to 80 hours of time within first year
Sick - up to 40 hours of time within first year
Floating Holiday - up to 8 hours of time within first year
Holiday - 10 paid holidays per year, these holidays are selected by the Division