QA Engineer, Validation
Full-time
FUJIFILM Biotechnologies
Position Overview The QA Engineer, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Job Description What You'll Do
- Performs a subject matter expert (SME) role within the QA team for the development of documents, processes, and procedures for the Validation program.
- Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
- Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment.
- Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility.
- Ensures project and operational quality objectives are met within desired timelines.
- Manufacturing (Clean Room) shop floor support for issue resolution, as needed.
- Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
- Must be flexible to support 24/7 manufacturing facility.
- Performs other duties, as assigned.
- Strong verbal and written communication skills to partner with different teams and stakeholders.
- Excellent oral and written communications skills and fluency in English.
- Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
- Ability to think critically and have superior problem-solving skills.
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
- Basic knowledge and application of cGMP compliance and other related regulations.
- Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
- Occasional opportunity for International and/or Domestic travel may be available.
- Bachelor's degree in Life Sciences or Engineering with 5 years of applicable industry experience; OR,
- Master's degree in Life Sciences or Engineering with 3 years of applicable industry experience; OR,
- PhD in Life Sciences or Engineering with 1 year of applicable experience.
- 3+ years of experience working in a GMP regulated environment.
- Experience in Validation and/or Quality oversight, in an FDA regulated facility.
- Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software.
- High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
- Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
- Understanding of Drug Substance, Drug Product or Finished Goods manufacturing processes.
- Experience with startup projects or initiatives.
- Training and/or familiarity with Quality Risk Management principles.
- Ability to discern audible cues.
- Ability to stand for prolonged periods of time for up to 120 minutes.
- Ability to sit for prolonged periods of time for up to 120 minutes.
- Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
- Ability to conduct work that includes moving objects up to 10 pounds.
Vacancy posted 9 days ago
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