Lead Engineer, CSV

OverviewLead Engineer, CSV role at Bristol Myers Squibb.The Lead Computer System Validation (CSV) Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent contributes to the completion of milestones associated with equipment qualification and systems validation. With minimal supervision and given general instructions, this individual performs routine tasks, applies basic analytical skills to solve common problems, and collaborates with the immediate supervisor and team to achieve goals while building trust and cross-functional relationships.Shifts Available Monday to Friday, 8 a.m. to 5 p.m.ResponsibilitiesSupports equipment qualification and validation vestigates and resolves Deviations, CAPA investigations, and other potential issues.Configures and documents the configuration of computerized systems to meet the requirements of 21 CFR Part 11.Supports the execution of equipment qualification and validation protocols.Supervises vendors for qualification pletes qualification and validation documentation with accuracy, completeness, and compliance to BMS standards.Owns lifecycle deliverables in equipment qualification and full CSV for single and multi-user computerized systems.Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, and Change itiates, manages, and leads projects of moderate scope within the functional area.Maintains positive relationships with team members and customers, promoting a collaborative learning environment.Authors quality procedures and training documents; delivers training on procedures and best practice to relevant novates and develops tools and solutions to improve efficiency and compliance.Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to the business area.Supports standardization efforts in the review and approval of validation deliverables.Provides excellent customer service and support; regularly reviews and responds to qualification and support terfaces with customers to ensure expectations are met; ensures equipment, facilities and programs are maintained in compliance.Knowledge & SkillsExcellent understanding of cGXP requirements and good documentation practices for systems, equipment, and instrumentation within the pharmaceutical industry.Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.Strong working knowledge of SDLC principles and standards.Ability to work with end users to identify and document User and Functional Requirements.Knowledge of pharmaceutical laboratory and manufacturing systems.Experience executing equipment qualification documents.Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups.Strong working knowledge of MS Windows client and server technologies.Strong task organization in a high-paced environment; ability to manage multiple tasks concurrently.Strong written and verbal communication skills and presentation abilities.Proficient in writing emails and reports; ability to follow instructions and interpret engineering manuals/drawings.Effective communication with employees, contractors, and vendors.Experience with technical writing and document development.Strong computer skills in Microsoft Office Suite and ability to learn new software as required for equipment qualification.Basic RequirementsBS degree or equivalent experience.Minimum 5 years of experience in an FDA-regulated industry.Working ConditionsOccasional stooping, bending, stretching, pushing, pulling, reaching and lifting up to 25 lbs.Ability to sit, stand, walk and move within the workspace for extended periods.Ability to perform repetitive tasks including hand/finger manipulation, grasping, pushing, and pulling.Primarily an office environment; may enter laboratory or GMP process areas with appropriate PPE.Ability to work safely whether alone or with pensationThe starting compensation for this job is a range from $86,490 - $104,800, plus incentive cash and stock opportunities (based on eligibility). Final, individual compensation will be decided based on demonstrated experience.Eligibility for benefits varies by job and location. For more on benefits, please visit the careers site. #J-18808-Ljbffr

Created: 2025-09-17