QA Engineer, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

The QA Engineer, Drug Substance Manufacturing (DSM) Operations provides quality oversight for DSM processes as they progress through the project phase toward operational readiness. The role oversees day-to-day quality assurance activities and helps resolve or mitigate issues. It serves as a subject matter expert within the QA team for developing DSM program documents, processes, and procedures.

The position assesses the quality impact of system and process modifications and oversees change management to ensure manufacturing systems are validated and remain validated through startup and commercial operation. It generates, reviews, and approves QA documentation, procedures, and processes; supports quality objectives and manufacturing operations in a cGMP-regulated facility; collaborates with other FUJIFILM Biotechnologies sites; contributes to improvement initiatives; and supports regulatory and third-party inspections.

The role works a 12-hour day shift on a 2-2-3 cadence, from 0600 to 1800, and must be flexible to support a 24/7 manufacturing facility. Occasional domestic and/or international travel may be available.

Requirements

• Bachelor's degree in Life Sciences or Engineering, or equivalent, and at least 5 years of applicable industry experience; or a master's degree in Life Sciences or Engineering and at least 3 years of applicable experience; or a Ph.D. in Life Sciences or Engineering and 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 and ability to prioritize tasks and meet tight deadlines.
• Critical thinking and strong problem-solving skills.
• Familiarity with 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-oriented 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 support a 24/7 manufacturing facility.
• Ability to stand for up to 30 minutes at a time, sit for up to 120 minutes at a time, perform repetitive motions involving the 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 for development of DSM program documents, processes, and procedures.
• Assess the impact of system and process modifications and oversee change management.
• Ensure manufacturing systems are validated and maintained in a validated state through startup and commercial operation.
• Generate, review, and approve QA documentation, procedures, and processes for operational readiness and manufacturing operations in a cGMP-regulated facility.
• Ensure project and operational quality objectives are met within desired timelines.
• Collaborate 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level