Senior Engineer, Cleaning Validation
About The Position
The Sr CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects. 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.”
Requirements
- Bachelor’s degree in Engineering
- 8 years of experience in validation activities in facilities, commissioning, and systems qualifications
- Experience with cGMP or working in another highly regulated industry
Nice To Haves
- Master’s degree in Engineering with 6 years of experience in validation activities in facilities, commissioning, and system qualifications
Responsibilities
- Acts as CQV Technical Lead for process support equipment to establish validation strategies, develop validation procedures that align with FDB’s Large Scale Biologics platform operating principles and regulatory requirements
- Provides guidance and leads the management of validation lifecycle for responsible areas for process support equipment and warehouse during Installation Verification (IV), Operational Verification (OV), Installation & Operational Qualification (IOQ), Performance Qualification (PQ) through Good Manufacturing Practices (GMP) release to decommissioning
- Provides technical support and leads external validation engineers through commissioning, qualification and validation of Large-Scale Biologics facilities and equipment
- Participates with FDB’s cross-network to inform and influence strategic management of validation programs, and working knowledge to incorporate global standards at the site level
- Liaises and collaborates with key stakeholders and support groups (e.g., Manufacturing, Process Science, Automation, Supply Chain, and Quality) to ensure FDB validation requirements are met
- Collaborates cross-functionally to ensure successful integration of CQV activities into projects
- Establishes Validation standard operating procedures (SOPs), Validation Project Plan (VPP), and Validation Master Plan (VMP) to ensure full cGMP compliance by operations launch
- Liaises with 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
- Leads the investigation of qualification deviations or discrepancies utilizing problem solving, and root cause analysis (RCA) to properly identify root causes and develop remediation plans (e.g., corrective and preventive action (CAPAs))
- Performs change control validation assessments to determine risk-based qualification, requirements for new systems, and changes to existing qualified systems
- Conducts impact and risk assessments and identifies risks and develops and leads the implementation of mitigation strategies
- Provides guidance and training to junior engineers for all CQV-related activities, as needed
- Other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
