Bristol Myers Squibb · 1 day ago
Manager, CSV - Equipment and Instrumentation
Summit, NJ
Full-time
Onsite
Mid, Senior Level
$95K/yr - $129K/yr
5+ years expBristol Myers Squibb is a company focused on transforming patients' lives through science. The Manager, CSV Equipment and Instrumentation - Cell Therapy is responsible for implementing and supporting manufacturing and laboratory equipment as well as computerized systems, ensuring compliance and fostering a collaborative team environment.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Supports equipment qualification and validation activities
Investigate and resolve Deviations, CAPA investigations and other potential issues
Configure and document the configuration of computerized systems to meet the requirements of CFR21 Part 11
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions
Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards
Independent ownership of all lifecycle deliverables in the Qualification of equipment 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, Change Controls
Initiates, manages, and leads projects of moderate scope and complexity within their functional area
Supervise and direct other team members to ensure completion of objectives
Manages projects of varying scope and complexity
Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment
Author quality procedures and training documents
Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners
Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment
Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
Support growing standardization efforts in the review and approval of Validation Deliverables
Provides excellent customer service and support
Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests
Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues. Interfaces with customers to ensure all expectations are being met
Ensure equipment, facilities and programs are maintained in compliance
Act as departmental lead and SME in both internal and regulatory audits
Qualification
Required
Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
Strong working knowledge of ISPE guidance, 21 CFR Part 1, and Data Integrity compliance
Strong working knowledge of SDLC principles and standards
Ability to work with the end user to identify and document User and Functional Requirements
Knowledge of pharmaceutical laboratory and manufacturing systems
Experience developing and 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 ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion
Ability to effectively manage multiple tasks and activities simultaneously
Strong written and verbal communication skills along solid presentation skills
Proficient at writing well-formulated emails and reports
Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task
Ability to effectively communicate with employees, contractors, and vendors
Experience with technical writing and document development / generation
Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification
BS degree or equivalent experience
Minimum 5 years of experience in FDA-regulated industry with at least 2 years of recent hands-on CSV and implementation experience related to manufacturing and laboratory local standalone computerized equipment and systems
Benefits
Medical, pharmacy, dental and vision care.
BMS Living Life Better program and employee assistance programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays)
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Tuition reimbursement and a recognition program.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase