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

Wellbeing programs

Retirement plan

Job summary

Bristol Myers Squibb seeks a Senior IT Compliance and CSV Engineer to support validated computerized systems and IT compliance at the Devens Campus, including the Cell Therapy Facility. The role requires CSV SME expertise, cross-functional collaboration, and strong regulatory knowledge.

Responsibilities include implementing CSV activities, change control, deviation management, audits, and risk assessment, while collaborating with global teams to ensure compliance and audit readiness.

Qualifications

• Bachelor’s degree in Engineering, Science, IT or related field.
• 3–5 years of CSV and IT compliance experience, preferably in cell therapy or biologics.
• Strong knowledge of FDA/EMA regulations and 21 CFR parts 11/210/211.
• Experience with quality systems, risk management, and audits.
• Excellent communication and technical writing skills.
• Lean Six Sigma and OPEX familiarity.

Responsibilities

• Execute CSV and IT compliance activities across the Devens Campus or related sites.
• Serve as CSV SME for automated systems and advise operations.
• Support deviation management, audits, change management, and risk management programs.
• Develop and maintain GxP documentation and ensure audit readiness.
• Collaborate with QA, Validation, Manufacturing, and IT teams on CSV initiatives.
• Assist in regulatory inspections and responses.

Skills

CSV expertise

IT compliance

Change management

Regulatory audits

Quality systems

Project management

Technical writing

Lean Six Sigma

Training development

Education

Bachelor's degree in Engineering/Science/IT

Tools

Regulatory compliance software

Quality management systems

Job description

Bristol Myers Squibb seeks a Senior IT Compliance and CSV Engineer to support validated computerized systems and IT compliance at the Devens Campus, including the Cell Therapy Facility. The role requires CSV SME expertise, cross-functional collaboration, and strong regulatory knowledge.

Responsibilities include implementing CSV activities, change control, deviation management, audits, and risk assessment, while collaborating with global teams to ensure compliance and audit readiness.