CQV Engineer: Commissioning & Validation Specialist

Qabird; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

BMS in Leiden is seeking an Engineer for Commissioning, Qualification & Validation (CQV) to support validation activities at the Leiden Cell Therapy Facility. You will execute IQ/OQ/PQ for Analytical Instruments, equipment, utilities and facilities, and ensure all protocols and reports comply with BMS requirements.

You will collaborate with Manufacturing, Technical Manufacturing, Facilities & Engineering and Quality to ensure data integrity and GDP compliance, while maintaining up-to-date

Qualifications

• Be proficient in GDP, GXP and GAMP concepts.
• Experience with IQ/OQ/PQ validation activities.
• Strong written and verbal communication; ability to work cross-functionally.

Responsibilities

• Write and execute validation protocols for IQ/OQ/PQ of instruments, utilities, and facilities.
• Prepare final reports and ensure alignment with cGMP and 21CFR Part 11 requirements.
• Coordinate with Manufacturing, Facilities, Quality, and Engineering teams to complete requalification activities.

Skills

GDP compliance

Documentation

Written communication

Verbal communication

Team collaboration

Problem solving

Education

BS in Engineering or Science

Tools

Analytical instruments

Job description

BMS in Leiden is seeking an Engineer for Commissioning, Qualification & Validation (CQV) to support validation activities at the Leiden Cell Therapy Facility. You will execute IQ/OQ/PQ for Analytical Instruments, equipment, utilities and facilities, and ensure all protocols and reports comply with BMS requirements.

You will collaborate with Manufacturing, Technical Manufacturing, Facilities & Engineering and Quality to ensure data integrity and GDP compliance, while maintaining up-to-date