QA Engineer, Drug Product - Second Shift

Fujifilm; Holly Springs (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina, seeks a QA Operations Engineer to drive quality oversight in Drug Product Manufacturing during second shift, with future 2-2-3 12-hour rotations. The role collaborates with the DP Quality team and cross-functional groups to ensure validated, compliant operations and change-management processes.

Responsibilities include developing and approving QA documents, supporting manufacturing readiness, line clearance, and regulatory readiness,

Qualifications

• Bachelor’s degree with 5 years of related experience, or Master’s with 3 years.
• Experience in a regulated GMP environment.
• Strong documentation and QA oversight capabilities.

Responsibilities

• Performs SME role within QA for development of documents, processes, and procedures.
• Generates, reviews, and approves QA documentation for manufacturing readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Manufacturing shop floor support, including AQL, critical process step verification, issue resolution, line clearance, alarm response, and work order oversight.
• Ensures project and operational quality objectives are met within desired timelines.
• Assess the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Performs other duties, as assigned.

Skills

QA oversight

GxP knowledge

QA documentation

Communication

Education

Bachelor’s degree

Master’s degree

Tools

TrackWise

Veeva

PAS-X

Smartsheet

Kneat

Job description

Position Overview

This position supports a Monday-Friday 3pm-11:30pm shift schedule. In the future, this will shift to a 2/2/3 6am-6pm or 6pm-6am schedule.

The QA Operations Engineer is responsible to help drive the Quality oversight for Drug Product Manufacturing area and processes during second shift. This role collaborates within the DP Quality team as well as with other cross-functional teams. Ensures that all DP systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Performs an SME role within the QA team for the development of documents, processes, and procedures for the Drug Product program.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Manufacturing shop floor support, including AQL, critical process step verification, issue resolution, line clearance, alarm response, and work order (WO) oversight.
• Ensures project and operational quality objectives are met within desired timelines.
• Assess the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Performs other duties, as assigned.

Knowledge, Skills, or Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly.
• Ability to think critically and have superior problem-solving skills, organization and planning skills.
• Team based attitude and ability to build relationships, and communicate effectively with others.
• Knowledge of Technology Transfer and/or Product Commercialization processes.
• High level of familiarity/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.
• This role supports a 24/7 operations environment and requires working nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. Upon hire, the position will be assigned to second shift on a 5x8 schedule and is eligible for shift differential in accordance with Company policy. The role is expected to transition to a 2-2-3, 12-hour rotating schedule, with shift differential eligibility per policy. The timing of the transition will be communicated in advance and is subject to business needs.

Minimum Requirements:

• Bachelor’s degree with5years of related experience; OR
• Master’s degreewith 3years ofrelatedexperience.
• Experience working in a regulated GMP environment.

Preferred Requirements:

• 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.

Working Conditions & Physical Requirements:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time, up to 120 minutes.
• Ability to sit for prolonged periods of time, up to 120 minutes.
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in warm/cold environment, 2-8 degrees C.

*LI-Onsite

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).