QA Engineer, DSM (Project QA)

Fujifilm; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Fujifilm is seeking a QA Engineer for Drug Substance Manufacturing in Holly Springs, North Carolina. This position ensures the Quality oversight of project processes and maintains validation throughout the lifecycle of DSM systems.

The ideal candidate should possess a relevant degree and several years of experience in a GMP regulated environment, providing oversight and ensuring project quality objectives are met in a cGMP facility.

Qualifications

• 5+ years of GMP industry experience or equivalent.
• 3+ years of experience in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations, FDA regulations.

Responsibilities

• Perform SME role for QA documents and processes.
• Assess impact of system/process modifications.
• Provide approval of lifecycle documentation.

Skills

GMP industry experience

Validation

Quality oversight

Experience with FDA regulations

Education

BS/BA in Life Sciences or Engineering

MS in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

ASTM E2500

Smartsheets

TrackWise

Veeva

Kneat validation software

Job description

Position Overview

QA Engineer, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Engineer, DSM ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

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.
• Performs other duties as assigned.

Minimum Requirements

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable GMP 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.
• Experience in Commissioning, Qualification, and Validation (CQV), Current Good Manufacturing Practices (cGMP) manufacturing operations and/or Quality oversight, in a Food and Drug Administration (FDA) regulated facility.

Preferred Requirements

• Experience and working knowledge of ASTM E2500, Smartsheets, TrackWise, Veeva, and/or Kneat validation software.
• Experience with Greenfield or startup projects or initiatives.
• Familiarity/understanding of qualification / validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT systems, clean rooms, classified spaces, controlled temperature units (CTUs), Cleaning verification and validation, Clean in Place (CIP) / Steam in Place (SIP), and associated testing methodologies.

Physical and Work Environment Requirements

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 30 minutes.

Ability to sit for prolonged periods of time 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.