QA Engineer, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

20h • Onsite

About The Position

The QA Engineer, Drug Substance Manufacturing (DSM) Operations helps drive Quality oversight of DSM processes through operational readiness during the project phase. The role provides quality assurance oversight of day-to-day activities and supports the resolution or mitigation of issues. It serves as a subject matter expert within the QA team for developing DSM program documents, processes, and procedures.

The position assesses the impact of system and process modifications and oversees change management to ensure manufacturing systems are validated and remain in a validated state through startup and commercial operation. It generates, reviews, and approves QA documentation, procedures, and processes for operational readiness and manufacturing operations in a cGMP-regulated facility. The role also supports quality objectives, cross-site process alignment, improvement initiatives, and regulatory and third-party inspections.

This position is based at FUJIFILM Biotechnologies’ facility in Holly Springs, North Carolina. It 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 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 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 partner with teams and stakeholders.
• Strong time-management skills and ability to meet tight deadlines and prioritize tasks effectively.
• Critical thinking and superior problem-solving skills.
• High 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 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 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 wrists, hands, and/or fingers, and move objects 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 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 into 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 or 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