Engineer Commissioning, Qualification & Validation (CQV)

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

R1604115 : Engineer Commissioning, Qualification & Validation (CQV)

Position Summary

Reporting to the Senior Manager, or designee, the CQV Engineer performs duties required to support validation activities for Leiden Cell Therapy Facility and ensures protocols and reports are in compliance with BMS requirements. This member will be responsible for executing and coordinating Installation, Operational and Performance qualification (IQ/OQ/PQ) activities when required.

Responsibilities

• Write protocols, perform field executions, and create final reports for Analytical Instruments/Equipment/utilities/facilities system qualifications.
• Communicate progress effectively.
• Ensure process and project documentation is accurate and updated.
• Maintain safe working environment.
• Follow company policies and procedures.
• Ensure accuracy of data presented in protocols and reports.
• Ensure data is recorded/reviewed using good documentation practices (GDP).
• Ensure calibration of equipment used for validation activities is up to date.
• Interface with customers to ensure all expectations are being met.
• Work collaboratively with Manufacturing, Technical Manufacturing, Manufacturing Technology, Facilities & Engineering and Quality.
• Coordinate and communicate with area owners to ensure completion of requalification and qualification activities.
• Perform requalification/revalidation activities as necessary.
• Provide input to Validation Services department SOPs review activities.
• Engage in and contribute to continuous improvement projects.
• No travel requirements.

Qualifications

• BS in Engineering or Science related discipline preferred with a minimum of 1-3 years’ experience performing and/or supporting pharmaceutical application validation in a GMP environment.
• Strong problem‑solving skills, strong verbal and written communication skills, and the ability to work independently.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Experience or close familiarity with analytical instruments/equipment/utility/facility qualifications and general commissioning, qualification and validation practices are desired.
• Experience collaborating with multi‑functional teams.
• Excellent communication and technical writing skills are required.

Equal Employment Opportunity

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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