CSV & IT Compliance Engineer — Life Sciences

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

Job summary

Bristol Myers Squibb seeks a specialized engineer to lead CSV and IT compliance activities across regulated systems. You will support validation, audits, change management, and risk processes while ensuring data integrity and alignment with regulatory standards.

The role emphasizes collaboration with Digital Plant teams, site operations, and external regulatory agencies, with a focus on continuous improvement and audit readiness. Devens, MA location; full-time employment.

Qualifications

• Bachelor's degree in Engineering, Science, IT or related IT/OT discipline with 1–3 years of CSV/compliance experience.
• Experience or training in internal audits/inspections is a plus.
• Knowledge of FDA, EMA, ICH guidelines and 21 CFR Parts 11/210/211 is preferred.

Responsibilities

• Execute CSV and IT compliance activities aligned with team/site objectives.
• Support CSV activities for computerized system changes and IT/Automation projects.
• Support deviation management, audits, change management, and risk management programs.
• Assist with CSV process implementation for Digital Plant and site groups.
• Contribute to data integrity and quality risk management programs.
• Provide IT quality support including investigations and CAPA reviews.
• Participate in regulatory and internal audits as a Digital Plant representative.

Skills

CSV knowledge

Regulatory compliance

Quality systems

Project management

Communication

Technical writing

Audits/inspections

FDA/regulatory interactions

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science/IT

Tools

GxP documentation tools

Regulatory knowledge tools

Job description

Bristol Myers Squibb seeks a specialized engineer to lead CSV and IT compliance activities across regulated systems. You will support validation, audits, change management, and risk processes while ensuring data integrity and alignment with regulatory standards.

The role emphasizes collaboration with Digital Plant teams, site operations, and external regulatory agencies, with a focus on continuous improvement and audit readiness. Devens, MA location; full-time employment.