Senior CSV Engineer — IT Compliance & Validation

Bristol-Myers Squibb; Massachusetts; On-site; USD 99,000 - 121,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing programs

401(k) plan and disability benefits

Paid time off and holidays

Job summary

Bristol Myers Squibb is seeking a Senior Engineer, IT Compliance and CSV, to lead computer system validation and IT compliance for the Devens Campus, including the Cell Therapy Facility. You will serve as the CSV SME, support risk management programs, and collaborate with Quality, Validation, Manufacturing, and enterprise teams.

The role requires strong regulatory knowledge (FDA/EMA) and experience in fully automated, validated manufacturing environments, with emphasis on compliance and audit

Qualifications

• Bachelor's degree in Engineering, Science, Information Technology, or related IT/OT discipline.
• 3–5 years of relevant CSV compliance experience, preferably including Cell Therapy or Biologics manufacturing.
• Strong knowledge of FDA/EMA regulatory requirements and 21 CFR 11; GMP-compliant validation experience.

Responsibilities

• Execute CSV and IT compliance activities for Devens Cell Therapy Facility.
• Serve as CSV SME for changes and advise operations.
• Support IT Deviation Management, Audits, Change Management, and Risk Management.
• Provide guidance on CSV process implementation and address deficiencies.
• Support Data Integrity and Quality Risk Management programs.
• Assist with investigations, CAPA, and deviations in QA systems.
• Participate in audits/inspections as Digital Plant rep.

Skills

CSV compliance

IT compliance

Validation

Regulatory affairs

Quality management

Project management

Technical writing

Training development

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Science, Information Technology, or related IT/OT

Tools

GAMP

GxP documentation tools

CAPA systems

Job description

Bristol Myers Squibb is seeking a Senior Engineer, IT Compliance and CSV, to lead computer system validation and IT compliance for the Devens Campus, including the Cell Therapy Facility. You will serve as the CSV SME, support risk management programs, and collaborate with Quality, Validation, Manufacturing, and enterprise teams.

The role requires strong regulatory knowledge (FDA/EMA) and experience in fully automated, validated manufacturing environments, with emphasis on compliance and audit