CSV & IT Compliance Engineer

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

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays each year

Comprehensive benefit plans (medical,…

Job summary

Bristol Myers Squibb in Devens, MA is seeking an Engineer for Computer Systems Validation and IT Compliance. The role focuses on executing CSV activities, supporting audits, and maintaining regulatory and data integrity standards within a fully automated, regulated manufacturing environment.

You will contribute to change management, risk management, and CAPA processes while collaborating across cross-functional teams.

Qualifications

• Bachelor’s degree in Engineering, Science, Information Technology, or a related IT/OT discipline, with a minimum of 1–3 years of relevant experience in Compliance and Computer System Validation (CSV).
• Experience/training in internal audits/inspections is a plus but not mandatory.
• Knowledge of regulatory CSV requirements (FDA, EMA, ICH) and 21 CFR Parts 11, 210/211, GAMP.

Responsibilities

• Execute CSV and IT compliance activities in line with team objectives.
• Support CSV activities for computerized system changes and IT/Automation projects.
• Assist with IT Deviation Management, Audit, Change Management and Risk Management programs.
• Support Digital Plant CSV process implementation and analyze deficiencies under supervision.
• Contribute to Data Integrity and Quality Risk Management programs.

Skills

Project management

Communication

Technical writing

Lean Six Sigma

OPEX principles

Education

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

Job description

Bristol Myers Squibb in Devens, MA is seeking an Engineer for Computer Systems Validation and IT Compliance. The role focuses on executing CSV activities, supporting audits, and maintaining regulatory and data integrity standards within a fully automated, regulated manufacturing environment.

You will contribute to change management, risk management, and CAPA processes while collaborating across cross-functional teams.