Senior CSV Engineer: IT Compliance & Validation

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

Benefits offered by this job

Health Coverage

401(k) plan

Paid Time Off

Wellbeing Programs

Job summary

Bristol Myers Squibb seeks a Senior Engineer, IT Compliance and CSV, to validate computerized systems and lead CSV programs at the Devens Campus, including the Cell Therapy Facility. You will work with Quality, Validation, Manufacturing, Engineering, and global teams, acting as site delegate as needed.

You will implement and track CSV processes, ensure regulatory readiness, and support audits, with emphasis on risk management and data integrity in a regulated environment.

Qualifications

• CSV and IT compliance experience in regulated life sciences.
• Regulatory knowledge including FDA/EMA and GxP.
• Familiar with 21 CFR Part 11 and data integrity concepts.
• Experience implementing quality systems, risk management, and audits.
• Excellent written and verbal communication; training materials.
• Lean Six Sigma knowledge is a plus.
• Mentor junior team members; collaborate across functions.

Responsibilities

• Execute CSV and IT compliance activities for regulated systems.
• Serve as CSV SME for changes and IT/Automation projects.
• Support Deviation Management, Audits, Change and Risk programs.
• Guide Digital Plant on CSV processes; address deficiencies.
• Support Data Integrity and Quality Risk programs.
• Review investigations, change controls, deviations; CAPA.
• Enter deviations, root cause, corrective actions, and reviews.
• Support audits/inspections as a Digital Plant representative.
• Develop and track SLAs for critical activities.
• Create and maintain GxP procedures and guidance.
• Execute validation and change management per regs.
• Monitor project progress; report to management.

Skills

CSV expertise

IT compliance

Regulatory knowledge

21 CFR Part 11

Data Integrity

Quality systems

Risk management

Regulatory audits

Documentation writing

Lean Six Sigma

Mentoring

Cross-functional collab

Education

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

Job description

Bristol Myers Squibb seeks a Senior Engineer, IT Compliance and CSV, to validate computerized systems and lead CSV programs at the Devens Campus, including the Cell Therapy Facility. You will work with Quality, Validation, Manufacturing, Engineering, and global teams, acting as site delegate as needed.

You will implement and track CSV processes, ensure regulatory readiness, and support audits, with emphasis on risk management and data integrity in a regulated environment.