CQV Engineer: GMP Validation & Commissioning

Biopharma Careers; Leiden; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Bristol Myers Squibb is seeking a CQV Engineer to support validation activities at the Leiden Cell Therapy Facility. You will execute IQ/OQ/PQ and coordinate qualification workflows to ensure compliant instrumentation and systems.

Join a multidisciplinary team with Manufacturing, QA, and Engineering to drive continuous improvement and maintain GDP-compliant records in a GMP environment.

Qualifications

• BS in Engineering or Science with 1–3 years of pharma validation in GMP.
• Strong problem-solving and communication skills; able to work independently.
• Knowledge of cGMP, GXP, GAMP, 21 CFR 11, EU GMP Annex 15, and GDP.
• Experience with analytical instruments/equipment qualifications and collaboration with QA/Manufacturing.

Responsibilities

• Write IQ/OQ/PQ protocols, perform field executions, and create final reports for qualifications.
• Coordinate validation activities and ensure compliance with BMS requirements.
• Maintain accurate, GDP-compliant documentation and data records.
• Collaborate with Manufacturing, Facilities, and Quality to support requalification activities.

Skills

Pharma validation

GMP/GXP knowledge

Documentation skills

Communication skills

Analytical instruments knowledge

Education

BS in Engineering or Science

Job description

Bristol Myers Squibb is seeking a CQV Engineer to support validation activities at the Leiden Cell Therapy Facility. You will execute IQ/OQ/PQ and coordinate qualification workflows to ensure compliant instrumentation and systems.

Join a multidisciplinary team with Manufacturing, QA, and Engineering to drive continuous improvement and maintain GDP-compliant records in a GMP environment.