Bristol Myers Squibb · 13 hours ago
Senior Engineer, IT Computer System Validation (CSV)
Devens, MA
Full-time
Onsite
Senior Level
$99K/yr - $121K/yr
6+ years expBristol Myers Squibb is a company that focuses on transforming the lives of patients through innovative work in various departments. The Senior Engineer, IT Computer System Validation, Cell Therapy Devens role involves managing computerized system validation activities and collaborating with key stakeholders to ensure compliance and quality assurance within the Digital Plant team.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Gain a thorough understanding of computer systems deployed at Devens CTF
Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects - advising operations on CSV matters and defending their work before regulatory agencies
Day-to-day oversight of the CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate
Drive and own the validation lifecycle documentation for newly implemented computerized systems
Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects
Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing
Participates in regulatory audits as Digital Plant secondary representative and assists in generating responses to audit observations
Provides IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities
Interact with Infinity (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed
Interact with ServiceNow to review and approve digital changes
Provide quality support of Digital Plant programs and system maintenance activities
Responsible for routine completion of quality events, quality actions, risk assessments, and other compliance documentation associated to computerized systems
Ability to support on-call deviations on a rotational basis
Perform project audits as the needs arise
Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated as it pertains to CSV responsibilities as needed
Qualification
Required
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required
A minimum of six (6) years of relevant experience in a regulated environment with at least four (4) years focused on quality assurance, validation, or compliance for computerized systems
Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR Part 11, and data integrity is required
Proficiency in project management, oral communication, and technical writing skills are required
Preferred
Knowledge of various Manufacturing IT systems such as Process Automation System (DeltaV), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), Laboratory Information Management System (Celabs) is preferred
Knowledge of various GxP supporting systems, such as Quality Management System (Infinity) and Document Management Systems (CelDox) is desirable
Knowledge of paperless validation systems, such as ValGenesis is preferred, not required
Project Management experience around manufacturing automation systems is desired
Experience working in a team-based environment with a diverse group of people
Experience managing multiple large projects and staffing resources accordingly
High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and understanding of quality risk management principles
Understanding of SOPs, cGMPs and other compliance requirements including guidelines within a regulatory environment (FDA, EU)
Benefits
Health Coverage Medical, pharmacy, dental, and vision care.
Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Eligibility Disclosure The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-25
The Motley Fool
2026-01-24
Company data provided by crunchbase