QA Engineer, Drug Substance Manufacturing Operations

FUJIFILM; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer for the DSM Operations team. The role focuses on quality oversight of drug substance manufacturing processes from project initiation through startup and commercial operation, including validation and change control.

The candidate will approve documentation, support regulatory inspections, and collaborate across FUJIFILM sites to improve processes. This on-site role requires a 12-hour day shift with a 2-2-3 cadence.

Qualifications

• BS/BA with 5+ years GMP experience or MS with 3+ years, or PhD with 1+ year in a GMP setting.
• Experience in Validation, GMP manufacturing operations and quality oversight in an FDA-regulated facility.

Responsibilities

• Provide QA oversight of DSM program documents, processes, and procedures.
• Assess impact of system and process changes and maintain validated state.
• Approve lifecycle documentation, risk assessments, specs, and validation reports.
• Generate and approve QA procedures for validation approaches and lifecycle documents.
• Support QA in manufacturing operations and regulatory inspections.

Skills

GMP compliance

Validation

Quality oversight

CFR Part 11

Problem solving

Cross-functional collaboration

Documentation quality

English proficiency

Project coordination

Education

BS/BA in Life Sciences or Engineering

MS in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Smartsheet

Trackwise

MasterControl

Kneat validation

ASTM E2500 knowledge

Job description

Position Overview

This position supports a 2/2/3 schedule from 6am-6pm.

The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800.

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 DSM program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then 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, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Collaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Works 12-hour shift on 2-2-3 cadence, 0600-1800.
• Performs other duties as assigned.

Knowledge, Skills, and Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Excellent oral and written communications skills and fluency in English.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to think critically and have superior problem-solving skills.
• High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and 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 with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience; OR,
• MS in Life Sciences or Engineering and 3+ years of applicable experience; OR,
• PhD in Life Sciences or Engineering and with 1+ years of applicable experience,
• 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.

Preferred Qualifications

• Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.
• Experience with startup projects or initiatives.
• Training and/or familiarity with Quality Risk Management Principles.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 30 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

*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]).