Senior CSV Engineer - IT Compliance for Regulated Systems

Bristol Myers Squibb; Harvard (MA); On-site; USD 99,000 - 121,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Disability insurance

Job summary

Bristol Myers Squibb is seeking a Senior Engineer, Computer Systems Validation at our Devens, MA site. You will drive CSV and IT compliance for regulated systems, partnering with Quality, Validation, Manufacturing, and Engineering to ensure audit-ready processes and robust data integrity.

Applicants should have 3–5 years in CSV/compliance in a life sciences setting, familiarity with FDA/EMA standards, and strong written communication.

Qualifications

• Bachelor's degree in relevant IT/OT field with 3–5 years CSV/compliance experience.
• Knowledge of FDA/EMA/ICH guidelines (Q7/Q8/Q9); Cell Therapy or Biologics context is a plus.
• Experience in regulated manufacturing environments with quality systems and validation.

Responsibilities

• Execute CSV and IT compliance activities across the Devens CTF.
• Serve as CSV SME for computerized system changes and IT projects.
• Support Deviation Management, Computer System Audit, Change Management, and Risk Management.

Skills

CSV expertise

Regulatory compliance

Project management

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Science/IT

Job description

Bristol Myers Squibb is seeking a Senior Engineer, Computer Systems Validation at our Devens, MA site. You will drive CSV and IT compliance for regulated systems, partnering with Quality, Validation, Manufacturing, and Engineering to ensure audit-ready processes and robust data integrity.

Applicants should have 3–5 years in CSV/compliance in a life sciences setting, familiarity with FDA/EMA standards, and strong written communication.