Manager, Computerized System Validation

Working with UsChallenging. 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 rich in diversity. 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. Read more:careers.bms.com/working-with-us .The CSV Senior Engineer / Manager works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is primarily an individual contributor but also leads supporting contract resources on a project basis. The CSV Senior Engineer / Manager will partner with Business Owners, Technical Owners and Quality to create, manage, and improve computerized systems validation deliverables for electronic systems (including data management), applications and associated controls to maintain data integrity supporting ALCOA+ principles throughout the validation lifecycle. The CSV Senior Engineer / Manager will have responsibility to ensure the validation of electronic systems and applications are documented in accordance with the relevant BMS procedures and regulations, and works to improve CSV and GxP data management processes for greater control and efficiency.REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Education:Bachelor's degree in a life sciences, engineering, or technology discipline. A combination of industry-specific education and work experience may be used to substitute this degree requirement.Experience:5+ years of direct experience with validation activities in a health authority regulated environment, strong knowledge of GAMP, risk-based approaches to validationStrong knowledge of health authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures5+ years of direct experience with Quality Systems records (Deviations, CAPAs, Change Requests, SOPs) and related activitiesDemonstrated understanding of management of electronic records / signatures in alignment with the ALCOA+ principles of data integrityStrong knowledge of global Health Authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signaturesFamiliar with development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ / OQ / PQ], Summary Reports, Trace Matrices, SOPs)Familiar with database constructs and data storage systems / technologyFamiliar with diverse computerized systems: instrument (laboratory / manufacturing) control systems, MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management SystemAbility to work independently and provide oversight for the work of contractors and consultantsDUTIES AND RESPONSIBILITIES:Author, review and/or approve applicable CSV documentationAssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operationsAssist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal proceduresPartner with IT Operations, Business Owners, Technical Owners and Quality on continuous improvement of data management practices and documentation relating to the application of ALCOA+ principles of GxP data integrity throughout the data lifecycle, including data mapping and criticality assessmentsSupport regulatory inspections as a subject matter expert (SME) as neededConduct impact assessments for changes related to validated computerized systemsSupport Quality Systems records investigations and analysesPerform periodic reviews of applicable SOPsManage supporting contract resources as neededAssist with site integration and enterprise harmonization activities as applicableWORKING CONDITIONS (US Only):Workwillbeperformedinanormal officeenvironment (or remotely)aswellascelltherapymanufacturingareas,server rooms, dataclosets andwarehouses.Must beabletodonappropriategowningforenteringcelltherapymanufacturingand testingareasinaccordancewithcompanyprocedures.Normal officetemperaturesandlightingconditionswillapply.Mustbeabletoliftup to 25pounds. Mustbeabletositforextendedperiods.Must beabletostandforextendedperiods.The starting compensation for this job is a range from $92,000 - $115,000, plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.Final individual compensation will be decided based ondemonstrated experience.For more on benefits, please visit:https://careers.bms.com/working-with-usEligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.Thisjobdescriptionisintendedtodescribethegeneral natureandlevelofworkbeingperformedby thepersonassignedtothisposition.Theprimary dutiesandresponsibilitiesareintendedtodescribethosefunctionsthatareessentialto theperformanceofthisjob.Thisjobdescriptiondoesnot stateorimplythat theabovearetheonlydutiesandresponsibilitiesassignedtothisposition. Thereareotherdutiesandresponsibilitiesthatareconsideredincidentalorsecondaryto theoverallpurposeofthisjob.Employeesholdingthispositionwillberequiredtoperform anyotherjob-relateddutiesasrequestedbymanagement.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.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.