Engineer Commissioning, Qualification & Validation (CQV)

Bristol Myers Squibb; Leiden; On-site; EUR 50,000 - 85,000; Full time

Job summary

Bristol Myers Squibb in Leiden is seeking a CQV Engineer to support validation activities for the Leiden Cell Therapy Facility. You will execute IQ/OQ/PQ activities, write protocols, perform field work, and coordinate with cross-functional teams to ensure GMP compliance and timely qualification deliverables.

The role requires strong documentation, analytical instrument knowledge, and the ability to work independently with minimal supervision, while maintaining safety and quality standards in a

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.
• No travel requirements.

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 GDP.
• Ensure calibration of equipment used for validation activities is up to date.
• Interfaces with customers to ensure all expectations are being met.
• Works 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.

Skills

Problem solving

Verbal communication

Written communication

Independent work

GDP familiarity

Collaboration

Technical writing

Attention to detail

Education

BS in Engineering or Science

Job description

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.
• Interfaces with customers to ensure all expectations are being met.
• Works 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.

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.
• No travel requirements.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

We will never request payments, financial information, or social security numbers during our application or recruitment process.

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R1604115: Engineer Commissioning, Qualification & Validation (CQV)