Equipment Validation Engineer II - GMP Compliance Expert

FUJIFILM; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking an Equipment Validation Engineer II to support qualification of manufacturing equipment and utilities in a GMP facility. You will develop risk-based validation strategies, author and run IQ/OQ/PQ protocols, and collaborate with cross-functional teams to ensure compliant, reliable operations.

Responsibilities include leading validation and re-qualification, developing test methods, data analysis, and maintaining ALCOA+ documentation.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 2–5+ years of hands-on validation in regulated environments (pharma, biotech, medical device, CDMO).
• 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 (GR&R, capability, sampling justification), and DOE basics.
• Experience with utilities and process equipment; understanding of calibration, metrology, and measurement traceability.
• Proficiency with validation and quality systems (eQMS/EDMS), CMMS, and basic scripting/spreadsheet analysis; strong technical writing.

Responsibilities

• 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.

Skills

IQ/OQ/PQ

Regulatory compliance

Risk assessment

Technical writing

Root cause analysis

Cross-functional collaboration

DOE basics

Metrology & calibration

Scripting/Spreadsheet analysis

Education

Bachelor’s degree in Engineering or related field

Tools

CMMS

eQMS/EDMS

Trackwise

Veeva

KNEAT

Statistical software

Job description

FUJIFILM Biotechnologies is seeking an Equipment Validation Engineer II to support qualification of manufacturing equipment and utilities in a GMP facility. You will develop risk-based validation strategies, author and run IQ/OQ/PQ protocols, and collaborate with cross-functional teams to ensure compliant, reliable operations.

Responsibilities include leading validation and re-qualification, developing test methods, data analysis, and maintaining ALCOA+ documentation.