Senior Engineer, IT Computer System Validation (CSV)

Senior Engineer – It Computer System Validation (Csv)

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Summary: We are seeking a highly skilled and motivated Senior Engineer – IT Computer System Validation (CSV) to join our team at the Devens Cell Therapy Facility (CTF). The Senior CSV Engineer will be responsible for managing the computerized system validation (CSV) activities for major projects to comply with regulatory requirements and industry standards. This role will be focused on development, execution, and maintenance of validation lifecycle documentation and helping support routine run the business operations related to computerized systems.

This position will work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology, Quality, Manufacturing Operations, and Validation.

Key Responsibilities:

• Gain a thorough understanding of computer systems deployed at Devens CTF.
• Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.
• 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.
• 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 ServiceNow to review and approve digital changes.
• Provide support of Digital Plant programs and system maintenance activities.
• Ability to support on-call deviations on a rotational basis.
• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.
• Provide CSV input to multi-function teams, advises operations on CSV matters, and defend their work before regulatory agencies.
• Duties may include internal compliance or efficiency improvement efforts within department.
• Mentor other IT CSV staff and provide guidance as necessary

Qualifications:

• 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.
• 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.
• 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).
• Proficiency in project management, oral communication, and technical writing skills are required.

Decision Making: Exercises sound judgment in making decisions and recommendations. Routinely makes decisions and takes or influences action on typical and atypical cases. Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Erroneous decisions or failure to achieve results will have significant financial implications, compliance implications or cause significant delays in schedules.

Coordinates with higher level IT Quality personnel on decisions and applies appropriate notification to management as appropriate.

Supervision Received: Incumbent typically manages a complete function or process, either through staff, the coordination of a team, or individual efforts. Receives assignments in the form of objectives and establishes goals to meet objectives. Work is measured based on meeting established objectives and schedule

Receives assignments which require the application of a defined process to complete the assignment. As such, specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly.

Working Conditions: Work within Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy. Occasional travel may be required to support validation activities and workshops at other sites.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.