GMP Equipment Validation Engineer II

FUJIFILM; North Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Onsite role

Job summary

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

The role emphasizes leadership in validation programs, data integrity, and collaboration with Maintenance/Engineering, with onsite presence during commissioning and

Qualifications

• Bachelor’s degree in Engineering or related scientific field.
• 2–5+ years of hands-on validation experience in regulated environments (pharma, biotech, medical device, CDMO).
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Strong knowledge of cGMP and FDA/ICH regulatory standards and data integrity.
• Familiarity with risk management tools (FMEA, HACCP, Fault Tree) and DOE basics.
• Experience with utilities and process equipment; understanding of calibration and metrology.

Responsibilities

• Author, review, and execute validation deliverables: URS, risk assessments, validation plans, IQ/OQ/PQ, reports, deviations, change controls.
• Lead validation and re-qualification for new and existing equipment, utilities, and systems.
• Coordinate vendor FAT/SAT and site qualification as required.
• Maintain compliant documentation in electronic quality systems (Trackwise, Veeva, KNEAT) and ensure data integrity.
• Support CSV/automation aspects (PLC/HMI, SCADA, data historians, audit trails, user access).
• Ensure EHS compliance during equipment commissioning, start-up, and qualification activities.

Skills

Problem solving

Cross-functional collaboration

Technical writing

Verbal and written communication

Project management

Scripting / data analysis

Education

Bachelor’s degree in Engineering

Tools

eQMS/EDMS

CMMS

Trackwise

Veeva

KNEAT

Job description

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

The role emphasizes leadership in validation programs, data integrity, and collaboration with Maintenance/Engineering, with onsite presence during commissioning and