GMP Equipment Validation Engineer II

FUJIFILM Biotechnologies; North Carolina; On-site; USD 95,000 - 125,000; Full time

Job summary

Fujifilm Biotechnologies in Morrisville/RTP, NC seeks an Equipment Validation Engineer II to qualify manufacturing equipment and utilities in a GMP facility. You will author and run IQ/OQ/PQ protocols, develop risk-based validation strategies, and collaborate with cross-functional teams to ensure compliant, reliable operations.

The role requires a Bachelor’s degree in Engineering and 2–5+ years of validated-environment experience, with strong knowledge of cGMP, FDA/ICH, and data integrity

Qualifications

• Bachelor's degree in Engineering or related field.
• 2–5+ years in validated environments (pharma/biotech/medical device).
• Experience authoring/executing IQ/OQ/PQ and validation reports.
• Knowledge of FDA/ICH regulations and data integrity.

Responsibilities

• Author, review and execute validation deliverables (URS, risk assessments, IQ/OQ/PQ).
• Lead validation for new and existing equipment and systems; site re-qualification.
• Develop test methods, sampling plans, and analysis; write summary reports.
• Maintain compliant documentation in electronic quality systems and ensure data integrity.

Skills

IQ/OQ/PQ execution

Validation planning

cGMP compliance

Risk assessment (FMEA)

Data integrity (ALCOA+)

Calibration/metrology

Regulatory documentation

Education

Bachelor's degree in Engineering

Tools

eQMS/EDMS

CMMS

Trackwise

Veeva

Job description

Fujifilm Biotechnologies in Morrisville/RTP, NC seeks an Equipment Validation Engineer II to qualify manufacturing equipment and utilities in a GMP facility. You will author and run IQ/OQ/PQ protocols, develop risk-based validation strategies, and collaborate with cross-functional teams to ensure compliant, reliable operations.

The role requires a Bachelor’s degree in Engineering and 2–5+ years of validated-environment experience, with strong knowledge of cGMP, FDA/ICH, and data integrity