QA Engineer, Drug Substance Manufacturing
About The Position
The QA Engineer, Drug Substance Manufacturing provides Quality Assurance oversight for Drug Substance Manufacturing processes through project-phase development and operational readiness. The role oversees day-to-day quality activities and helps resolve or mitigate issues in a cGMP-regulated manufacturing environment. As a subject matter expert within the QA team, the engineer develops and reviews documents, processes, and procedures for the DSM program. The position assesses the quality impact of system and process changes and oversees change management to ensure Manufacturing Systems are validated before use and remain in a validated state through startup and commercial operation. It also supports operational readiness and manufacturing operations, helps meet quality objectives and timelines, collaborates with other company sites, and participates in improvement initiatives and inspections. The role is based in the context of FUJIFILM Biotechnologies’ bioproduction facility in Holly Springs, North Carolina. 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 Ph.D. 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 and fluency in English.
- Strong time-management skills and ability to prioritize tasks and meet tight deadlines.
- Critical-thinking and problem-solving skills.
- Familiarity with or understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing and IT systems, and related methodologies.
- Understanding of GAMP5, data integrity, and the 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 with others.
- 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 bring positive energy to a dynamic work environment and embrace the company’s Genki culture.
- Ability to discern audible cues; stand for up to 30 minutes, 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.
- Experience with Smartsheet, Trackwise, MasterControl, and/or Kneat validation software.
- Experience with startup projects or initiatives.
- Training in or familiarity with Quality Risk Management principles.
Responsibilities
- Serve as a QA subject matter expert for developing DSM program documents, processes, and procedures.
- Assess the impact of system and process modifications and maintain oversight of change management processes.
- Ensure Manufacturing Systems are validated before startup and maintained in a validated state through startup and commercial operation.
- Provide oversight and approval of 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 covering the validation approach and Manufacturing Systems lifecycle documents.
- 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.
- Be flexible to support a 24/7 manufacturing facility.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
