Senior Engineer, IT Computer System Validation; CSV

Summary

Work with us at Bristol Myers Squibb to manage the computerized system validation (CSV) activities and major projects at the Devens Cell Therapy Facility (CTF). This role works closely with Digital Plant (IT/Automation) subject‑matter experts and other stakeholders such as Manufacturing Science and Technology, Quality Engineering, and Manufacturing Operations.

• Gain a thorough understanding of computer systems deployed at Devens CTF.
• Act as CSV subject‑matter expert for computerized‑system related changes and associated IT/Automation projects, advising operations on CSV matters and defending their work before regulatory agencies.
• Oversee the CSV program day‑to‑day, ensuring standardization and consistency of qualification testing documents and associated testing deviations, and escalating to the 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 risk assessments, specifications, pre‑ and post‑approval qualification testing.
• Participate in regulatory audits as Digital Plant secondary representative and assist in generating responses to audit observations.
• Provide IT quality support to the 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 Service Now 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 with computerized systems.
• Support on‑call deviations on a rotational basis.
• Perform project audits as needs arise.
• Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies used to maintain the validated state are regularly reviewed and updated as needed.

• 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.
• Knowledge of manufacturing IT systems such as Process Automation System (Delta
  
  V), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), Laboratory Information Management System (Celabs). Preferred but not required.
• Knowledge of GxP supporting systems such as Quality Management System (Infinity) and Document Management Systems (Cel Dox). Desirable.
• Knowledge of paperless validation systems such as Val Genesis. 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 experience in computer system and pharmaceutical computerized system fields and an understanding of quality risk management principles.
• Understanding of SOPs, cGMPs and other compliance requirements including guidelines within a regulatory environment (FDA, EU).
• Proficiency in project management, oral communication, and technical writing skills.
• Decision making: exercise sound judgment in making decisions and recommendations, routinely making decisions and taking or influencing action on typical and atypical cases.
• Coordinate…