Senior CQV Engineer - Commissioning & Validation

Bristol-Myers Squibb Co; Cruiserath; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Zusammenfassung

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

You will plan risk-based protocols, ensure inspection-ready documentation, and drive continuous improvement across MPCC and SDPF facilities, collaborating with QA, Manufacturing, Engineering, MS&T and Regulatory Affairs.

Qualifikationen

• 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 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; ability to work independently and as part of a team.
• Proficiency in Microsoft Office and validation software tools.
• Advantageous: experience in biologics or pharmaceutical manufacturing.
• Desirable: familiarity with DeltaV, MES or SAP.

Aufgaben

• Support commissioning, qualification and validation across MPCC and SDPF facilities.
• Develop commissioning, qualification and validation plans and risk-based strategies.
• Author, execute and report IQ, OQ and PQ protocols for equipment.
• Manage CSV deliverables: URS, FS, DS, IQ/OQ/PQ and traceability matrices.
• Ensure computerised systems comply with 21 CFR Part 11, EU Annex 11 and data integrity.
• Ensure qualification activities meet FDA, EMA, ICH and industry standards.
• Assess impact of changes and deviations on validation status; re-qualification as needed.
• Maintain validation documentation; support regulatory inspections.
• Participate in root cause analysis, deviation investigations and CAPA.
• Collaborate with QA, Manufacturing, Engineering, MS&T, Regulatory Affairs.
• Identify opportunities for process improvement and enhanced compliance.
• Coach and support colleagues on CQV processes.

Kenntnisse

IQ/OQ/PQ

GAMP 5

21 CFR Part 11

Annex 11

Regulatory knowledge

Risk-based validation

Technical writing

Communication skills

Team collaboration

DeltaV familiarity

Ausbildung

Bachelor's degree (Engineering, Life Sciences, Chemistry)

Tools

DeltaV

MES

SAP

Jobbeschreibung

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

You will plan risk-based protocols, ensure inspection-ready documentation, and drive continuous improvement across MPCC and SDPF facilities, collaborating with QA, Manufacturing, Engineering, MS&T and Regulatory Affairs.