Sr Engineer Computer Systems Validation
Bristol Myers Squibb
August 17, 2026
Remote friendly (Devens, MA)
United States
IT
Position Summary
The Senior Engineer, IT Compliance and CSV supports computerized system validation, IT compliance, and change/deviation management for regulated computerized systems across the Devens Campus (including the Cell Therapy Facility). Executes System Life Cycle deliverables; serves as a CSV SME; supports IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs; works with Quality, Validation, Manufacturing, Engineering, and enterprise teams.
Duties/Responsibilities
- Execute CSV and IT compliance activities (including for Devens CTF) aligned to team/site objectives.
- Serve as CSV SME for computerized system changes and related IT/Automation projects; advise operations.
- Support IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs.
- Guide Digital Plant/site groups on CSV process implementation; analyze/address process deficiencies.
- Support Data Integrity and Quality Risk Management programs.
- Provide IT quality support: review/approve investigations and change controls; own computerized system events and CSV activities.
- Enter/support deviations, actions, root cause analysis, CAPA, and effectiveness reviews in the Quality Management System.
- Participate in regulatory/internal audits and inspections; respond to audit observations.
- Implement/track Service Level Agreements (SLAs) for business-critical activities.
- Develop/maintain GxP procedures and guidance for compliance and audit readiness.
- Execute validation/implementation/change management for regulated IT systems.
- Track project progress; provide updates via tools/dashboards.
- Improve efficiency/quality of CSV documentation and processes; evaluate technologies/tools/process improvements.
Qualifications
- Bachelor’s degree (Engineering/Science/IT or related IT/OT), 3–5 years relevant Compliance and CSV experience (preferably Cell Therapy/Biologics Manufacturing).
- Knowledge of regulatory CSV requirements (FDA/EMA; e.g., ICH Q7/Q8/Q9).
- Working knowledge: 21 CFR Part 11; 21 CFR Parts 210/211; GAMP (ISO 9001 is a plus).
- Working knowledge of health authority/digital asset requirements incl. Data Integrity.
- Experience with quality systems, risk management, audit readiness, deviation and change management in regulated automated manufacturing.
- Ability to represent department to stakeholders and regulatory agencies.
- Ability to support US FDA and other agency interactions.
- Strong project management, communication, and technical writing; training experience is a plus.
- Lean Six Sigma and OPEX understanding.
- Ability to innovate, synthesize cross-functional solutions, collaborate, and manage multiple priorities.
- Internal audit/inspection experience advantageous.
- Willingness to mentor and share knowledge.
Compensation/Benefits
- Devens, MA: $99,480–$120,551 (full-time). Additional incentive cash/stock may be available (eligibility-based).
- Benefits include health coverage, wellbeing support, and financial protection; work-life benefits include Paid Time Off (specific to role/location).
Application Instructions
- None provided in the job description text.
The Senior Engineer, IT Compliance and CSV supports computerized system validation, IT compliance, and change/deviation management for regulated computerized systems across the Devens Campus (including the Cell Therapy Facility). Executes System Life Cycle deliverables; serves as a CSV SME; supports IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs; works with Quality, Validation, Manufacturing, Engineering, and enterprise teams.
Duties/Responsibilities
- Execute CSV and IT compliance activities (including for Devens CTF) aligned to team/site objectives.
- Serve as CSV SME for computerized system changes and related IT/Automation projects; advise operations.
- Support IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs.
- Guide Digital Plant/site groups on CSV process implementation; analyze/address process deficiencies.
- Support Data Integrity and Quality Risk Management programs.
- Provide IT quality support: review/approve investigations and change controls; own computerized system events and CSV activities.
- Enter/support deviations, actions, root cause analysis, CAPA, and effectiveness reviews in the Quality Management System.
- Participate in regulatory/internal audits and inspections; respond to audit observations.
- Implement/track Service Level Agreements (SLAs) for business-critical activities.
- Develop/maintain GxP procedures and guidance for compliance and audit readiness.
- Execute validation/implementation/change management for regulated IT systems.
- Track project progress; provide updates via tools/dashboards.
- Improve efficiency/quality of CSV documentation and processes; evaluate technologies/tools/process improvements.
Qualifications
- Bachelor’s degree (Engineering/Science/IT or related IT/OT), 3–5 years relevant Compliance and CSV experience (preferably Cell Therapy/Biologics Manufacturing).
- Knowledge of regulatory CSV requirements (FDA/EMA; e.g., ICH Q7/Q8/Q9).
- Working knowledge: 21 CFR Part 11; 21 CFR Parts 210/211; GAMP (ISO 9001 is a plus).
- Working knowledge of health authority/digital asset requirements incl. Data Integrity.
- Experience with quality systems, risk management, audit readiness, deviation and change management in regulated automated manufacturing.
- Ability to represent department to stakeholders and regulatory agencies.
- Ability to support US FDA and other agency interactions.
- Strong project management, communication, and technical writing; training experience is a plus.
- Lean Six Sigma and OPEX understanding.
- Ability to innovate, synthesize cross-functional solutions, collaborate, and manage multiple priorities.
- Internal audit/inspection experience advantageous.
- Willingness to mentor and share knowledge.
Compensation/Benefits
- Devens, MA: $99,480–$120,551 (full-time). Additional incentive cash/stock may be available (eligibility-based).
- Benefits include health coverage, wellbeing support, and financial protection; work-life benefits include Paid Time Off (specific to role/location).
Application Instructions
- None provided in the job description text.