Sr. Engineer 1, Commissioning Qualification and 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 Data Science, Biotechnology, or Chemical Engineering with 5 years of related experience
Nice To Haves
- 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
Responsibilities
- Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed
- Coordinates with cross-functional teams to deliver projects on time and in full completeness
- Contributes to building and maintaining routine statistical process control methods and multivariate models for process trending and monitoring
- Supports ad hoc statistical analysis, as needed
- Documents process performance and product health through process trending, monitoring, and supporting annual product reviews and manufacturing campaign summary reports
- Supports technical risk assessments for new manufacturing processes from a process analytics perspective
- Serves as on-call for process analytics issues and concerns
- Supports role in Good Manufacturing Practices (GMP) environment
- Provides technical support for root cause analysis (RCA) and process assessments in response to process deviations, as needed
- Assists with close out of deviations, as required
- Supports generation of master batch records (MBRs) and sample plans, as needed
- Assists site data stewardship activities by ensuring data and analyses are easily findable, accessible, interoperable, and reusable to internal and external stakeholders
- Supports in informatics and data systems improvement initiatives to improve scalability, manufacturability, reliability, yield and cost
- Supports the curation of critical knowledge related to process analytics systems and multivariate modeling
- Other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
