CSV & IT Compliance Engineer - Regulated Systems

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

Job summary

Bristol-Myers Squibb Co. in Devens, MA, is seeking an Engineer specializing in Computer Systems Validation and IT Compliance. You will execute CSV activities, support system changes and IT projects, and contribute to QA/Regulatory programs.

The role emphasizes regulatory knowledge, collaboration across teams, and process improvements in a fully regulated manufacturing environment. On-site work in Devens is expected with competitive benefits.

Qualifications

• Bachelor’s degree in Engineering, Science, Information Technology, or a related IT/OT discipline with 1–3 years of relevant experience in Compliance and CSV.
• Experience or training in internal audits/inspections is a plus.
• Knowledge of regulatory CSV requirements (FDA/EMA, ICH Q7/Q8/Q9) and 21 CFR 11, 21 CFR Parts 210/211, GAMP.
• Exposure to quality systems, risk management, audit readiness, deviation management, and change management.
• Willingness to interact with US FDA and regulatory agencies under guidance.

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.

Skills

Project management

Communication

Technical writing

Lean Six Sigma

OPEX principles

Cross-functional collaboration

Training materials development

Innovative problem solving

Adaptability

Education

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

Job description

Bristol-Myers Squibb Co. in Devens, MA, is seeking an Engineer specializing in Computer Systems Validation and IT Compliance. You will execute CSV activities, support system changes and IT projects, and contribute to QA/Regulatory programs.

The role emphasizes regulatory knowledge, collaboration across teams, and process improvements in a fully regulated manufacturing environment. On-site work in Devens is expected with competitive benefits.