Senior Engineer 1/2, CQV Upstream & Downstream

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

FUJIFILM Biotechnologies is hiring a Senior Engineer 1 or Senior Engineer 2 in Commissioning, Qualification, and Validation (CQV) for upstream and downstream operations at its Holly Springs, North Carolina site. Senior Engineer 1 leads commissioning and qualification of equipment and systems in an assigned area. Senior Engineer 2 serves as a subject matter expert and leads CQV for multiple site areas. Both roles lead the CQV team through the validation lifecycle, investigate deviations and root causes, establish procedures and other documentation, collaborate with internal and external stakeholders to meet regulatory and quality requirements, and train and guide junior engineers. The position acts as CQV technical lead for process support equipment, establishing validation strategies and procedures aligned with FDB’s Large Scale Biologics platform principles and regulatory requirements. It guides validation lifecycle management for process support equipment and warehouse areas, from installation verification through qualification, GMP release, and decommissioning. The role provides technical support to external validation engineers, coordinates with cross-functional stakeholders, and helps integrate CQV activities into projects. The role establishes validation SOPs, Validation Project Plans, and Validation Master Plans to support cGMP-compliant operations. It coordinates preparation and approval of qualification and validation documents, assesses change controls and risks, investigates qualification discrepancies, and develops remediation and mitigation plans. Senior Engineer 2 additionally participates in the global CQV subject matter expert network and prepares and presents validation lifecycle materials for audits and client visits. The position is based at FUJIFILM Biotechnologies’ Holly Springs, North Carolina facility. The company describes the site as a biopharmaceutical manufacturing facility offering drug substance production, fill-finish, and packaging. Work may involve production and mechanical areas, outdoor conditions, warm or cold environments, small or enclosed spaces, and heights greater than four feet.

Requirements

Bachelor’s degree in Engineering.
Senior Engineer 1: 8 years of experience in validation activities in facilities, commissioning, and systems qualifications.
Senior Engineer 2: 12 years of experience in validation activities in facilities, commissioning, and systems qualifications.
Experience with cGMP or work in another highly regulated industry.
Effective written and oral communication skills and ability to present information to others.
Proficient knowledge of Microsoft Office, including Word and PowerPoint.
Knowledge of ISPE and PDA industry guidelines and applicable U.S. and international regulations, including FDA, ICH, ISO, and EU requirements for validation of GMP facilities.
Ability to meet the stated physical demands, including standing or sitting for up to 240 minutes, climbing, repetitive hand and wrist motions, operating machinery or power tools, and moving objects up to 50 pounds.

Nice To Haves

Senior Engineer 1: Master’s degree in Engineering with 6 years of experience in validation activities in facilities, commissioning, and system qualifications.
Senior Engineer 2: Master’s degree in Engineering with 8 years of experience in validation activities in facilities, commissioning, and system qualifications.
Experience working with ISPE and PDA guidelines and U.S. and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
Experience with Biologics License Application (BLA) submissions.
For Senior Engineer 2: Ability to develop effective working relationships internally and externally.
For Senior Engineer 2: Advanced strategic planning and problem-solving skills.

Responsibilities

Act as CQV technical lead for process support equipment, establishing validation strategies and procedures aligned with FDB’s Large Scale Biologics operating principles and regulatory requirements.
Guide and lead validation lifecycle management for assigned process support equipment and warehouse areas, from Installation Verification, Operational Verification, IOQ, and PQ through GMP release and decommissioning.
Provide technical support and lead external validation engineers through commissioning, qualification, and validation of Large-Scale Biologics facilities and equipment.
Participate with the FUJIFILM Biotechnologies cross-network to inform validation program strategy and incorporate global standards at the site level.
Collaborate with Manufacturing, Process Science, Automation, Supply Chain, Quality, and other stakeholders to ensure validation requirements are met.
Integrate CQV activities successfully into cross-functional projects.
Establish validation SOPs, Validation Project Plans, and Validation Master Plans to support cGMP compliance by operations launch.
Coordinate with the CQV Document Generation Lead to generate and approve DQ, Design Reviews, SLIA, Test Matrices, Risk Assessments, QA Vendor Assessments, FAT, SAT, CTP, and IOQ Protocols.
Lead investigations of qualification deviations or discrepancies, determine root causes, and develop remediation plans such as CAPAs.
Perform change-control validation assessments to determine risk-based qualification requirements for new systems and changes to qualified systems.
Conduct impact and risk assessments, identify risks, and lead implementation of mitigation strategies.
Provide guidance and training to junior engineers on CQV activities.
Perform other duties as assigned.
For Senior Engineer 2: Participate in the Global SME Network to support cross-site CQV alignment.
For Senior Engineer 2: Prepare presentation packages for the FDBN Validation Lifecycle program for audits and client visits and participate in presentations as required.