QA Engineer, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

14h • Onsite

About The Position

The QA Engineer, Drug Substance Manufacturing (DSM) Operations helps drive Quality oversight for DSM processes through operational readiness during the project phase. The role provides quality assurance oversight of day-to-day activities and supports resolution or mitigation of issues. It serves as a subject matter expert within the QA team, developing documents, processes, and procedures for the DSM program. The role assesses the impact of system and process modifications and oversees change management to ensure manufacturing systems are validated and maintained in a validated state through startup and commercial operation. It generates, reviews, and approves QA documentation and supports manufacturing operations in a cGMP-regulated facility, while ensuring project and operational quality objectives are met on schedule. The position collaborates with other FUJIFILM Biotechnologies sites, participates in process optimization and improvement initiatives, and supports regulatory agency and third-party inspections. The schedule is a 12-hour day shift on a 2-2-3 cadence, 0600–1800. The role must be flexible to support a 24/7 manufacturing facility; occasional domestic and/or international travel may be available. Other duties may be assigned.

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, including fluency in English.
• Strong time-management skills and ability to meet tight deadlines and prioritize tasks effectively.
• 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 application of 21 CFR Parts 820 and 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.
• Basic knowledge and application of cGMP compliance and related regulations.
• Ability to support a 24/7 manufacturing facility and work the stated 12-hour shift schedule.
• Ability to stand for up to 30 minutes, sit for up to 120 minutes, perform repetitive wrist, hand, and/or finger motions, 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 subject matter expert within the QA team 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 and maintained in a validated state through startup and commercial operation.
• 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.

What This Job Offers

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