{"id":3774373,"url":"https://alion.io/job/bristol-myers-squibb-manager-engineering-computer-systems-validation-csv","title":"Manager, Engineering Computer Systems Validation (CSV)","company":{"id":7994,"name":"Bristol Myers Squibb","domain":"bms.com","url":"https://alion.io/company/bms","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":65,"ghost_share":0.077,"stale_share":0.231,"repost_share":0.138,"time_to_fill_p50_days":24,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Management","role_family":"Management","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"Cell Culture","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-04T22:39:26Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-05T22:06:46Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"At Bristol Myers Squibb, our employees often ask, “Who are you working for?”-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.\nPosition Summary\nBMS Cruiserath Biologics is seeking to recruit one permanent Manager, Engineering Computer Systems Validation (CSV). The role is part of the Engineering Commissioning, Qualification and Validation (CQV) team and operates under a campus approach, with responsibility for the CSV programme across both the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites. The role reports to the Sr. Manager, Engineering CQV.\nThe Manager, Engineering CSV will lead the CSV programme and a team of CSV Senior Specialists, developing and implementing CSV strategies and driving continuous improvement to enhance the efficiency, compliance, and effectiveness of CSV and CQV operations across both facilities. CQV experience, including equipment commissioning and qualification (IQ, OQ, PQ), is an advantage given the close link between validated equipment and the computerised systems that control it.\nRole Overview\nThe Manager, Engineering CSV is responsible for leading the CSV programme across the MPCC and SDPF facilities. The role encompasses CSV strategy and master planning in accordance with GAMP 5, 21 CFR Part 11, and Annex 11, oversight of deliverable authoring and review, data integrity assurance across all validated computerised systems on campus, management of the CSV team, and close collaboration with IT, Engineering, Quality Assurance, Regulatory Affairs, MS&T, and Manufacturing. The role works alongside the equipment qualification team so that automated equipment and control systems are commissioned, qualified, and validated in an integrated and efficient manner.\nKey Responsibilities\nLead the CSV programme across MPCC and SDPF, reporting progress and escalations to the Sr. Manager, Engineering CQV.\nDevelop and maintain the CSV strategy, validation master plan, and risk-based approaches in line with GAMP 5, 21 CFR Part 11, and EU Annex 11.\nPlan, coordinate, and oversee CSV activities across the full system lifecycle, from concept and supplier assessment through periodic review and retirement, ensuring timely completion and adherence to budget.\nOversee the authoring, review, and approval of CSV deliverables, including validation plans, user and functional requirements, risk assessments, configuration and design specifications, test protocols (IQ/OQ/PQ), traceability matrices, SOPs, and summary reports.\nEnsure data integrity compliance (ALCOA+) across all validated computerised systems, including process control, laboratory, manufacturing execution, and enterprise systems.\nProvide oversight of validated state maintenance, including change control, periodic review, backup and recovery, access management, audit trail review, and system decommissioning.\nConduct and review risk assessments and develop and implement mitigation strategies.\nProvide expert technical input to changes, deviations, CAPAs, investigations, and periodic reviews that may affect the validated state of computerised systems.\nWork with the equipment qualification team to coordinate commissioning, qualification, and validation of automated equipment and systems, ensuring qualification readiness and operational handover.\nCollaborate with IT, Engineering, Quality Assurance, Regulatory Affairs, MS&T, Manufacturing, and vendors to align validation activities with project and operational objectives across both facilities.\nReview and approve vendor documentation, supplier assessments, and factory and site testing outputs for computerised systems.\nAct as the primary CSV representative during regulatory inspections, health authority audits, and internal audits, addressing findings and implementing corrective actions as required.\nProvide training, mentorship, and performance management to CSV team members to support professional growth and development.\nIdentify, champion, and implement innovation, standardisation, and continuous improvement opportunities across CSV and CQV, including risk-based and computer software assurance (CSA) approaches where appropriate.\nTechnical Scope\nCSV lifecycle management for GxP computerised systems, including planning, specification, risk assessment, testing, release, and retirement.\nProcess control and automation systems such as DeltaV, manufacturing execution systems (MES), and enterprise systems such as SAP, together with laboratory and building management systems.\nSupplier assessment and use of vendor documentation, including leveraging supplier testing in a risk-based manner.\nData integrity (ALCOA+), electronic records and signatures, audit trail review, user access management, and backup and recovery.\nLifecycle maintenance of validated state, including change impact assessment, periodic review, and risk-based revalidation.\nIntegration of CSV with equipment commissioning and qualification for automated equipment and control systems.\nQualifications and Experience\nBachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or a related discipline.\nExtensive experience in Computer Systems Validation (GAMP 5, 21 CFR Part 11, Annex 11) within a GMP-regulated biologics or pharmaceutical environment.\nDemonstrated experience leading and managing CSV or validation teams in a project or operational setting.\nExperience developing and implementing CSV strategies and managing validation projects from concept through to lifecycle closure.\nStrong understanding of regulatory requirements (FDA, EMA, ICH), data integrity expectations (ALCOA+), and industry standards (GAMP 5, ISPE Baseline Guides).\nExperience with risk-based validation approaches and quality risk management, including change control, deviations, investigations, and CAPAs.\nProven experience supporting health authority inspections and internal audits, including responding to observations and implementing CAPAs.\nExcellent technical writing, review, communication, and presentation skills.\nProven ability to collaborate with cross-functional teams and manage multiple stakeholders across a multi-facility campus environment.\nDemonstrated track record of driving process improvement and compliance optimisation.\nFamiliarity with systems such as DeltaV, MES, SAP, or laboratory and building management systems is highly desirable.\nExperience in commissioning, qualification, and validation (CQV) of equipment (IQ/OQ/PQ), including requalification, is an advantage.\nPrevious experience in biologics manufacturing, aseptic processing, or sterile drug product operations is an advantage.\nRegulatory and Industry Knowledge\nApplicable GMP and regulatory expectations from the FDA, EMA, and other relevant health authorities.\nGAMP 5, 21 CFR Part 11, and EU GMP Annex 11, together with current industry guidance on computerised systems and risk-based validation.\nGood Documentation Practice and data integrity principles applicable to electronic and paper records.\nWhy you should apply\nYou will help patients in their fight against serious diseases\nYou will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.\nYou’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym\n#LI-Onsite\nWe hire for skills and capabilities, not just credentials - if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.\nHow We Work\nWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.\nSupporting People with Disabilities\nBMS 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 to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.\nCandidate Rights\nBMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.\nFor roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/\nFor roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.\nData Protection\nWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.\nAny data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.\nIf this posting is missing required information required by local law or incorrect, contact BMS at  with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.\nR1608130 : Manager, Engineering Computer Systems Validation (CSV)","description_format":"text","description_chars":10269,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Annual leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Washington","iso":null,"kind":"city"},{"name":"California","iso":null,"kind":"city"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Oncology Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-04T22:39:26Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":24,"reasons":["conf:1","velocity","win:early","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/bristol-myers-squibb-manager-engineering-computer-systems-validation-csv","json_url":"https://alion.io/job/bristol-myers-squibb-manager-engineering-computer-systems-validation-csv.json","meta":{"generated_at":"2026-11-06T01:38:27Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":2713,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":7994},"rest":"https://alion.io/mcp/rest/get_company?id=7994"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbristol-myers-squibb-manager-engineering-computer-systems-validation-csv"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbristol-myers-squibb-manager-engineering-computer-systems-validation-csv"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbristol-myers-squibb-manager-engineering-computer-systems-validation-csv"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/bristol-myers-squibb-manager-engineering-computer-systems-validation-csv\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbristol-myers-squibb-manager-engineering-computer-systems-validation-csv"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3774373}},{"tool":"search_jobs","arguments":{"company":"bms.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3774373},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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