Senior Engineer, Cleaning Validation

Fujifilm•Holly Springs, NC

About The Position

The Senior Engineer, Cleaning Validation (identified in the position overview as Sr CQV Engineer 1) leads commissioning and qualification of equipment and systems in an assigned site area. The role leads the CQV team through the validation lifecycle, investigates deviations and root causes, and establishes standard operating procedures and other validation documents. It collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and comply with regulatory and quality requirements. The role also provides training and guidance to junior engineers. As CQV Technical Lead for process support equipment, the engineer establishes validation strategies and develops procedures aligned with FDB’s Large Scale Biologics platform operating principles and regulatory requirements. The position guides validation lifecycle management for process support equipment and the warehouse, from Installation Verification and Operational Verification through qualification, GMP release, and decommissioning. It supports and leads external validation engineers working on Large-Scale Biologics facilities and equipment and works across site and network teams to integrate CQV activities into projects and validation programs. The engineer develops and maintains validation procedures and plans, coordinates validation documentation, conducts risk and change-control assessments, and leads investigation and remediation of qualification deviations. The role is based in the context of FUJIFILM Biotechnologies’ biopharmaceutical manufacturing facility in Holly Springs, North Carolina.

Requirements

Bachelor’s degree in Engineering.
Eight years of experience in validation activities involving facilities, commissioning, and systems qualifications.
Experience with cGMP or work in another highly regulated industry.

Nice To Haves

Master’s degree in Engineering with six years of experience in validation activities involving facilities, commissioning, and system qualifications.

Responsibilities

Act as CQV Technical Lead for process support equipment, establishing validation strategies and developing procedures aligned with FDB’s Large Scale Biologics platform operating principles and regulatory requirements.
Guide and lead validation lifecycle management for process support equipment and the warehouse, from Installation Verification (IV), Operational Verification (OV), Installation & Operational Qualification (IOQ), and Performance Qualification (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 FDB’s cross-network to inform and influence strategic management of validation programs 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.
Collaborate cross-functionally to integrate CQV activities successfully into projects.
Establish validation SOPs, Validation Project Plans (VPPs), and Validation Master Plans (VMPs) to support full cGMP compliance by operations launch.
Liaise 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, using problem-solving and root cause analysis to identify 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 develop and lead implementation of mitigation strategies.
Provide guidance and training to junior engineers for CQV-related activities as needed.
Perform other duties as assigned.