QA Engineer, Drug Product - Second Shift

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The QA Operations Engineer supports Quality oversight for the Drug Product Manufacturing area and processes during second shift. The role works within the Drug Product Quality team and with cross-functional teams to ensure systems and processes are operated and maintained as intended. It focuses on consistent policy administration, Quality oversight of shift activities, and resolving or mitigating issues during operations. The position is initially assigned to a Monday–Friday, 3:00 p.m.–11:30 p.m. schedule, with shift differential eligibility under Company policy. The role supports a 24/7 operating environment and requires nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. It is expected to transition to a 2-2-3, 12-hour rotating schedule; the transition timing will be communicated in advance and is subject to business needs. FUJIFILM Biotechnologies is building a biopharmaceutical manufacturing facility in Holly Springs, North Carolina, with drug substance production, fill-finish, and packaging capabilities. The company describes its culture as dynamic and purpose-driven, guided by the Group Purpose of “giving our world more smiles.”

Requirements

Bachelor’s degree and 5 years of related experience, or a master’s degree and 3 years of related experience.
Experience working in a regulated GMP environment.
Strong verbal and written communication skills to collaborate with different teams and stakeholders.
Strong time-management skills and ability to prioritize tasks and meet tight deadlines.
Ability to adapt and adjust plans in a fast-paced environment.
Critical thinking, problem-solving, organization, and planning skills.
Team-oriented approach and ability to build relationships and communicate effectively.
Knowledge of Technology Transfer and/or Product Commercialization processes.
High level of familiarity with or understanding of hygienic utilities, quality systems, automation, manufacturing and IT systems, and validation of production equipment.
Understanding of Data Integrity and application of 21 CFR Part 820 and Part 11.
Ability to work nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned.
Ability to discern audible cues; inspect or perform tasks with 20/20 corrected vision and distinguish colors; stand and sit for periods up to 120 minutes; perform repetitive motions involving wrists, hands, and/or fingers; move objects up to 10 pounds; and bend, push, pull, reach to retrieve materials 18–60 inches high, and use twisting motions.
Ability to work in warm or cold environments at 2–8 degrees C.

Nice To Haves

Understanding of formulation, aseptic filling, and/or visual inspection.
Working knowledge and experience with Trackwise, Veeva, PAS-X, Smartsheet, and/or Kneat.
Experience with startup projects.
Training and/or familiarity with Quality Risk Management principles.

Responsibilities

Serve as a subject matter expert within the QA team for developing Drug Product program documents, processes, and procedures.
Generate, review, and approve QA documentation, procedures, and processes for operational readiness and QA support of manufacturing operations in a cGMP-regulated facility.
Provide manufacturing shop-floor support, including AQL, critical process-step verification, issue resolution, line clearance, alarm response, and work order oversight.
Ensure project and operational quality objectives are achieved within desired timelines.
Assess the impact of system and process modifications and oversee change management to ensure Manufacturing systems remain in a validated state through startup and commercial operation.
Oversee and approve system and process lifecycle documentation, including risk and impact assessments and product, process, and equipment specifications.
Participate in optimization and improvement initiatives and support regulatory agency and third-party inspections.
Perform other duties as assigned.