Manager, Csv, Cell Therapy

Working with Us
Challenging. 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 Manager, CSV Cell Therapy 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 in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Essential Functions:

• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
• Develops validation/qualification deliverables such as Validation Plans,
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
• Manages projects of varying scope and complexity.
• Develops protocols, and associated reports while adhering to a change management process.
• Provide direct oversight of CSV personnel providing hands-on leadership.
• Support the continuous improvement of the CQV program.
• Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
• Supports the execution of equipment qualifications and validation protocols
• Provides technical support and guidance on calibration and equipment qualification issues, investigations, deviations and CAPA actions. Interfaces with customers to ensure all expectations are being met.
• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to BMS standards.
• Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
• Provides excellent customer service and support.
• Supports calibration, equipment qualification and validation activities.
• Supervises vendors for qualification functions.
• Configures and documents the configuration of computerized systems

Required Competencies-Knowledge, Skills, and Abilities:

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
• Experience executing equipment qualification documents
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
• 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 work with the end user to identify and document User and Functional Requirements
• Working knowledge of standard networking principles and technologies
• Ability to interact effectively with laboratory, QA, and Facilities groups
• Strong working knowledge of MS Windows client and server technologies.

Education & Experience:

• Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV
• BS degree in Engineering / Computer Science or equivalent

Working Conditions:

• Ability to work safely when working alone or working with others.
• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
• Environment may include working in office or in a laboratory / manufacturing area.

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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 Careers
With 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 Protocol
Physical 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 to [email protected]. Visit careers.bms.com/eeo-accessibility to 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.

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