Senior Engineer, IT Computer System Validation (CSV) - ...

, ATTENTION MILITARY AFFILIATED JOB SEEKERS, - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to, Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is 'On-Site' at the location detailed in the job post., Challenging. Meaningful. Life-changing. Those arenât 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. Youâll 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 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 teract 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 , , , , ,

Created: 2025-10-04