QA Engineer, Drug Substance Manufacturing
About The Position
The QA Engineer, Drug Substance Manufacturing supports Quality oversight of Drug Substance Manufacturing (DSM) processes through project development and operational readiness. The role provides quality assurance oversight of day-to-day activities and helps resolve or mitigate issues. As a subject matter expert within the QA team, the engineer develops documents, processes, and procedures for the DSM program and supports manufacturing systems from validation through startup and commercial operation. The role oversees and approves system and process lifecycle documentation, including risk and impact assessments, specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports. It also develops, reviews, and approves QA procedures and documentation for validation, operational readiness, and manufacturing operations in a cGMP-regulated facility. The engineer works to meet project and operational quality objectives and timelines, collaborates with other FUJIFILM Biotechnologies sites, participates in improvement initiatives, and supports regulatory and third-party inspections. Occasional domestic or international travel may be available, and flexibility to support a 24/7 manufacturing facility is required.
Requirements
- Bachelor's degree in Life Sciences or Engineering, or equivalent, with at least 5 years of applicable industry experience; or a master's degree in Life Sciences or Engineering with at least 3 years of applicable experience; or a PhD in Life Sciences or Engineering with at least 1 year of applicable experience.
- At least 3 years of experience working in a GMP-regulated environment.
- Experience in validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.
- Strong verbal and written communication skills, including fluency in English, and the ability to work with different teams and stakeholders.
- Strong time management and ability to prioritize tasks and meet tight deadlines.
- Critical thinking and superior problem-solving skills.
- Familiarity with or understanding of validation for production equipment, hygienic utilities, quality systems, automation, manufacturing and IT systems, and related methodologies.
- Understanding of GAMP5, data integrity, and application of 21 CFR Part 820 and Part 11.
- Understanding of cell culture, upstream processes, large-scale recovery, and/or downstream processes.
- Team-based attitude and ability to build relationships and communicate effectively.
- Collaborative attitude and willingness to work with global peers and cross-functional teams toward company and department goals.
- Basic knowledge and application of cGMP compliance and related regulations.
- Ability to support a 24/7 manufacturing facility with flexibility.
- Ability to discern audible cues; stand for up to 30 minutes and sit for up to 120 minutes; perform repetitive motions involving wrists, hands, and/or fingers; and move objects weighing up to 10 pounds.
Nice To Haves
- Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl, and/or Kneat validation software.
- Experience with startup projects or initiatives.
- Training and/or familiarity with Quality Risk Management principles.
Responsibilities
- Serve as a subject matter expert within the QA team in developing documents, processes, and procedures for the DSM program.
- Assess the impact of system and process modifications and oversee change management to ensure manufacturing systems are validated and remain in a validated state through startup and commercial operation.
- Oversee and approve system and process lifecycle documentation, including risk and impact assessments, product, process, and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Generate, review, and approve QA procedures for validation approaches and lifecycle documentation for manufacturing systems.
- Generate, review, and approve QA documentation, procedures, and processes for operational readiness and QA support of manufacturing operations in a cGMP-regulated facility.
- Ensure project and operational quality objectives are met within desired timelines.
- Collaborate and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
- Participate in optimization and improvement initiatives.
- Support regulatory agency and third-party inspections.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
