CQV Engineer: Commissioning & Validation Expert

Bristol Myers Squibb UK & Ireland; Ireland; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Job summary

Bristol Myers Squibb UK & Ireland is seeking a permanent Senior Specialist, Engineering CQV to lead qualification of process and utility equipment and the validation of computerised systems across MPCC and SDPF facilities.

You will plan risk-based validation, author IQ/OQ/PQ protocols, and ensure compliance with FDA/EMA regulations. Collaborate with QA, Manufacturing and Regulatory teams for continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field.
• 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 knowledge of regulatory requirements and standards (FDA, EMA, ICH, GAMP 5).
• Experience with risk-based validation approaches (ICH Q9).
• Excellent problem-solving, analytical and technical writing skills.
• Strong communication and interpersonal skills; able to work independently or in a team.
• Proficiency in Microsoft Office and validation software tools.
• Desirable experience in biologics/start-up facilities; familiarity with DeltaV, MES or SAP.

Responsibilities

• Support commissioning, qualification and validation activities across MPCC and SDPF facilities.
• Develop validation plans and risk-based strategies for equipment and systems.
• Author, execute and report IQ, OQ and PQ protocols including functional testing and start-up support.
• Manage CSV deliverables (URS, FS, DS, IQ/OQ/PQ, traceability matrices).
• Ensure compliance with 21 CFR Part 11, EU Annex 11 and data integrity requirements.
• Adhere to regulatory requirements (FDA, EMA, ICH) and industry standards (GAMP 5).
• Assess changes and deviations; initiate re-qualification or re-validation as needed.
• Maintain audit-ready validation documentation and support inspections.
• Participate in CAPA, deviation investigations and root cause analysis.
• Collaborate with QA, Manufacturing, Engineering, MS&T, and Regulatory Affairs; report progress to stakeholders.
• Identify opportunities for process improvement and enhanced compliance.
• Coach colleagues on CQV processes and procedures.

Skills

Equipment qualification

Computer systems validation

Regulatory knowledge

Risk-based validation

Technical writing

Communication skills

Validation tools

DeltaV / MES / SAP familiarity

Education

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

Tools

DeltaV

MES

SAP

Job description

Bristol Myers Squibb UK & Ireland is seeking a permanent Senior Specialist, Engineering CQV to lead qualification of process and utility equipment and the validation of computerised systems across MPCC and SDPF facilities.

You will plan risk-based validation, author IQ/OQ/PQ protocols, and ensure compliance with FDA/EMA regulations. Collaborate with QA, Manufacturing and Regulatory teams for continuous improvement.