Senior CSV Engineer - IT Compliance for Regulated Systems

Biopharma Careers; Harvard (MA); On-site; USD 99,000 - 121,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) plan

Paid Time Off

Global Shutdown

Job summary

Bristol Myers Squibb in Devens, MA, is seeking a Senior Engineer for IT Compliance and CSV to support validation of regulated computerized systems across the facility. You will serve as CSV SME, advise on changes, support deviation management, audits, and risk management, collaborating with Quality, Validation, Manufacturing and enterprise teams.

This role involves implementing CSV processes, maintaining regulatory documentation, and contributing to continuous improvement in a fully automated

Qualifications

• Bachelor's degree in Engineering, Science, Information Technology, or related IT/OT
• 3–5 years in Compliance and Computer System Validation (CSV)
• Knowledge of FDA/EMA requirements and GAMP guidance

Responsibilities

• Execute CSV and IT compliance activities for Devens CTF and other regulated systems
• Serve as CSV SME for computerized system changes and IT/Automation projects
• Support IT Deviation Management, Computer System Audit, Change Management, and Risk Management
• Provide guidance on CSV processes and participate in regulatory audits/inspections
• Track project progress and update management with dashboards

Skills

CSV Knowledge

IT Compliance

Quality Systems

Project Management

Regulatory Liaison

Documentation

Education

Bachelor's degree in Engineering/IT

Job description

Bristol Myers Squibb in Devens, MA, is seeking a Senior Engineer for IT Compliance and CSV to support validation of regulated computerized systems across the facility. You will serve as CSV SME, advise on changes, support deviation management, audits, and risk management, collaborating with Quality, Validation, Manufacturing and enterprise teams.

This role involves implementing CSV processes, maintaining regulatory documentation, and contributing to continuous improvement in a fully automated