Senior Engineer 1/2, CQV Upstream & Downstream
About The Position
The Senior Engineer, CQV Upstream & Downstream leads commissioning and qualification (CQV) for process support equipment and systems at the site. Depending on level, the role supports assigned areas or serves as a subject matter expert across multiple areas. The engineer leads CQV teams through the validation lifecycle, deviation investigations and root cause analysis, and develops standard operating procedures and other validation documents. The position works with internal and external stakeholders to ensure equipment, systems, and validation strategies align with global standards, regulatory requirements, and quality standards, and provides guidance and training to junior engineers. The role establishes validation strategies and procedures consistent with FDB’s Large Scale Biologics platform operating principles and regulatory requirements. It leads lifecycle activities 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. It supports external validation engineers and collaborates with Manufacturing, Process Science, Automation, Supply Chain, Quality, and other groups to integrate CQV activities into projects. The engineer establishes validation SOPs, Validation Project Plans (VPPs), and Validation Master Plans (VMPs), and coordinates documentation such as design qualification and reviews, risk assessments, vendor assessments, FAT, SAT, CTP, and IOQ protocols. The role assesses change controls and risks, develops mitigation strategies, and leads qualification deviation investigations and remediation plans, including CAPAs. Senior Engineer II 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 in the bioproduction facility in Holly Springs, North Carolina. Work may take place in production and mechanical spaces, outdoors, in warm or cold conditions, at heights, and in small or enclosed spaces. Some spaces may require hearing protection and enrollment in a hearing conservation program.
Requirements
- Bachelor’s degree in Engineering.
- Senior Engineer I: 8 years of experience in validation activities involving facilities, commissioning, and systems qualifications.
- Senior Engineer II: 12 years of experience in validation activities involving facilities, commissioning, and systems qualifications.
- Experience with cGMP or work in another highly regulated industry.
- Effective written and oral communication and ability to present information.
- Proficient knowledge of Microsoft Office, including Word and PowerPoint.
- Knowledge of ISPE and PDA industry guidelines and U.S. and international regulations and standards, including FDA, ICH, ISO, and EU requirements, for validation of GMP facilities.
- Senior Engineer II: Ability to develop effective working relationships internally and externally.
- Senior Engineer II: Advanced strategic planning and problem-solving skills.
Nice To Haves
- Senior Engineer I: Master’s degree in Engineering with 6 years of experience in validation activities involving facilities, commissioning, and system qualifications.
- Senior Engineer II: Master’s degree in Engineering with 8 years of experience in validation activities involving facilities, commissioning, and system qualifications.
- Experience applying ISPE and PDA guidelines and U.S. and international regulations (FDA, ICH, ISO, EU) to validation of GMP facilities.
- Experience with Biologics License Application (BLA) submissions.
Responsibilities
- Act as CQV technical lead for process support equipment and establish validation strategies and procedures aligned with FDB platform principles and regulatory requirements.
- Lead validation lifecycle management for responsible process support equipment and warehouse areas, from IV, OV, IOQ, and PQ through GMP release and decommissioning.
- Provide technical support and lead external validation engineers during commissioning, qualification, and validation of facilities and equipment.
- Participate in cross-network coordination to inform 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 meet validation requirements and integrate CQV into projects.
- Establish validation SOPs, Validation Project Plans, and Validation Master Plans to support cGMP compliance by operations launch.
- Coordinate generation and approval of DQ, design reviews, SLIA, test matrices, risk assessments, QA vendor assessments, FAT, SAT, CTP, and IOQ protocols.
- Lead qualification deviation and discrepancy investigations using problem-solving and root cause analysis, and develop remediation plans such as CAPAs.
- Perform change-control validation assessments to determine risk-based qualification requirements for new and changed systems.
- Conduct impact and risk assessments, identify risks, and lead implementation of mitigation strategies.
- Provide guidance and training to junior engineers on CQV activities.
- Senior Engineer II: Participate in the Global SME Network to support cross-site CQV alignment.
- Senior Engineer II: Prepare validation lifecycle presentations for internal and external audits and client visits, and present as required.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
