Senior Specialist, Engineering Commissioning, Qualification & Validation

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

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a permanent Senior Specialist, Engineering Commissioning, Qualification and Validation (CQV) . The role sits within the Engineering CQV team, which supports the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites, and reports to the Sr. Manager, Engineering CQV. You will take ownership of the qualification of process and utility equipment and the validation of the computerised systems that control it, from commissioning and start-up through to routine operation. You will plan and execute risk-based protocols, keep validation documentation inspection-ready, and drive continuous improvement across both facilities.

Key Responsibilities

• Work as part of the Engineering CQV team under a campus approach, supporting commissioning, qualification and validation activities across both the 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.

Qualifications & Experience

• 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.
• Proficiency in Microsoft Office and relevant validation software tools.
• Advantageous: experience in a biologics or pharmaceutical manufacturing environment.
• Desirable: experience of a biologics start-up facility and familiarity with systems such as DeltaV, MES or SAP.

Why you should apply

You will help patients in their fight against serious diseases

You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior