Backed by 500 Global.
About the role
We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, Industrial) or related scientific field
- 2–5+ years of hands-on validation experience in regulated environments (pharma, biotech, medical device, CDMO, or related)
- Demonstrated experience authoring and executing IQ/OQ/PQ protocols and validation reports
- Strong working knowledge of cGMP and applicable regulations/standards: FDA 21 CFR Parts 210/211/820, ICH Q8–Q10, Annex 15, GAMP 5, ISO 13485/9001, data integrity principles
- Familiarity with risk management tools (FMEA, HACCP, Fault Tree), statistics (e.g., GR&R, capability, sampling justification), and DOE basics
- Experience with utilities and process equipment, understanding of calibration, metrology, and measurement traceability
More about this role
We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations.
At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.
Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
Fujifilm is globally headquartered in Tokyo with...
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