QA Engineer, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

The QA Engineer, Drug Substance Manufacturing supports Quality oversight of Drug Substance Manufacturing 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 oversees validation and lifecycle documentation for manufacturing systems. The position also supports operational readiness and quality oversight of manufacturing operations in a cGMP-regulated facility, with a focus on meeting project and operational quality objectives and timelines. 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, and 5 or more years of applicable industry experience; or a master’s degree in Life Sciences or Engineering and 3 or more years of applicable experience; or a Ph.D. in Life Sciences or Engineering and 1 or more years 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 different teams and stakeholders.
• Strong time-management skills and ability to meet tight deadlines and prioritize tasks effectively.
• Critical thinking and superior 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, ability to build relationships, and effective communication 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 discern audible cues; 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 or 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.
• Ability to travel occasionally domestically and/or internationally.

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 to ensure manufacturing systems are validated and maintained 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 documents 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 achieved within desired timelines.
• Collaborate and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Participate in optimization and improvement initiatives and support regulatory agency and third-party inspections.
• Perform other duties as assigned.

What This Job Offers

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