Senior CQV Engineer – Biologics Validation & Compliance

Bristol-Myers Squibb; Cruiserath; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days leave

Life assurance

On-site gym

Job summary

BMS Cruiserath Biologics is seeking a permanent Senior Specialist, Engineering CQV to own the qualification of process and utility equipment and the validation of computerised systems from commissioning through routine operation.

You will plan risk-based protocols, maintain audit-ready validation documentation, and drive continuous improvement across MPCC and SDPF, collaborating with Quality Assurance, Manufacturing, Engineering, MS&T and Regulatory Affairs to ensure compliance with FDA,

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field.
• Demonstrated experience in equipment qualification (IQ/OQ/PQ) and/or computer systems validation (GAMP 5, 21 CFR Part 11, Annex 11) in a regulated environment.
• Strong working knowledge of regulatory requirements and industry standards (FDA, EMA, ICH, GAMP 5).
• Experience applying risk-based validation approaches and quality risk management (ICH Q9).
• Excellent problem-solving, analytical and technical writing skills.
• Strong communication and interpersonal skills, with the ability to work independently and as part of a team.

Responsibilities

• Work as part of the Engineering CQV team under a campus approach, supporting commissioning, qualification and validation activities across MPCC and SDPF facilities.
• Develop commissioning, qualification and validation plans and risk-based strategies for new and existing process and utility equipment and computerised systems.
• Author, execute and report IQ, OQ and PQ protocols for equipment, including functional testing, troubleshooting and support for start-up activities.
• Author and manage CSV deliverables across the system lifecycle in line with GAMP 5, including URS, FS, DS, IQ/OQ/PQ and traceability matrices.
• Ensure computerised systems comply with 21 CFR Part 11, EU Annex 11 and data integrity requirements.
• Ensure all qualification and validation activities meet applicable regulatory requirements (FDA, EMA, ICH) and industry standards (GAMP 5, ASTM).
• Assess the impact of changes, deviations and process modifications on equipment and system validation status, and initiate re-qualification or re-validation where required.
• Maintain validation documentation so that it is current, complete and audit-ready, and support regulatory inspections and audits.
• Participate in root cause analysis, deviation investigations and CAPA.
• Collaborate with Quality Assurance, Manufacturing, Engineering, MS&T and Regulatory Affairs, and report plans, progress and results to key stakeholders.
• Identify and implement opportunities for process improvement and enhanced compliance.
• Coach and support colleagues on CQV processes and procedures.

Skills

CQV experience

Regulatory understanding

Problem-solving

Technical writing

Communication skills

Independent worker

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry or related field

Tools

GAMP 5

21 CFR Part 11

EU Annex 11

DeltaV

MES

SAP

Job description

BMS Cruiserath Biologics is seeking a permanent Senior Specialist, Engineering CQV to own the qualification of process and utility equipment and the validation of computerised systems from commissioning through routine operation.

You will plan risk-based protocols, maintain audit-ready validation documentation, and drive continuous improvement across MPCC and SDPF, collaborating with Quality Assurance, Manufacturing, Engineering, MS&T and Regulatory Affairs to ensure compliance with FDA,