Equipment Validation Engineer 2

Position Overview

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.

Company Overview

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 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do:

• Author, review, and execute validation deliverables: URS, risk assessments (FMEA), validation plans, IQ/OQ/PQ protocols, reports, deviation investigations, and change controls. • Lead validation and re-qualification for new and existing equipment, utilities, and systems (e.g., fermenters, autoclaves, vessels, CIP/SIP, WFI/clean steam, environmental chambers). • Lead and execute the site re-qualification program. • Perform equipment/system impact assessments and determine validation strategies based on risk and regulatory requirements. • Develop and implement test methods, acceptance criteria, sampling plans, and data collection tools; perform data analysis and write summary reports. • Ensure calibration and preventive maintenance requirements are defined, documented, and integrated with CMMS/Metrology. • Troubleshoot equipment performance issues; partner with Maintenance/Engineering for root cause analysis and CAPA implementation. • Maintain compliant documentation within electronic quality systems (e.g., Trackwise, Veeva, KNEAT) and ensure data integrity (ALCOA+). • Support CSV/automation aspects where applicable (PLC/HMI, SCADA, data historians, audit trails, backups, user access). • Execute validation activities under change control, author justifications, and assess validation impact for changes, deviations, and nonconformances. • Support internal and external audits; present validation rationale, evidence, and traceability. • Contribute to SOP/work instruction development, templates, and validation standards; drive continual improvement and harmonization. • Coordinate vendor FAT/SAT and onsite qualification as required. • Ensure EHS compliance during equipment commissioning, start-up, and qualification activities.