CSV & IT Compliance Engineer (Life Sciences)

Bristol-Myers Squibb Company; Harvard (MA); On-site; USD 84,000 - 102,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Stock options and discretionary Incent

Job summary

Bristol Myers Squibb seeks an IT CSV specialist to support validation, compliance, and quality programs in a regulated life sciences environment. You will assist in audits, CAPAs, and change control, working with cross-functional teams to uphold data integrity and compliance standards.

The role emphasizes collaboration, continuous improvement, and readiness for regulatory interactions, with opportunities to grow expertise in biopharma IT governance and process optimization.

Qualifications

• Bachelor’s degree in Engineering, Science, IT, or related IT/OT field with 1–3 years in CSV/compliance.
• Knowledge of FDA/EMA/global regulatory requirements (ICH Q7/Q8/Q9) in life sciences.
• Experience with 21 CFR Part 11 and GMP/GxP environments is preferred.
• Willingness to engage with regulatory agencies under guidance and training.

Responsibilities

• Execute CSV and IT compliance activities aligned with team/site goals.
• Support CSV changes, IT deviations, audits, and change management.
• Assist Digital Plant teams with CSV process implementation and CAPA reviews.
• Contribute to data integrity, quality risk management, and investigations.
• Document deviations, root causes, and effectiveness reviews in the QM system.
• Support audits/inspections and SLA tracking for critical activities.
• Develop procedures and guidance to maintain audit readiness.

Skills

CSV Compliance

IT Validation

Regulatory Knowledge

Technical Writing

Education

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

Job description

Bristol Myers Squibb seeks an IT CSV specialist to support validation, compliance, and quality programs in a regulated life sciences environment. You will assist in audits, CAPAs, and change control, working with cross-functional teams to uphold data integrity and compliance standards.

The role emphasizes collaboration, continuous improvement, and readiness for regulatory interactions, with opportunities to grow expertise in biopharma IT governance and process optimization.