Manager, Computer System Validation (CSV) – Cell Therapy

Bristol-Myers Squibb Company; Summit (NJ); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Manager, CSV Cell Therapy to oversee qualification, validation, and lifecycle deliverables for equipment and computerized systems across multi-user sites. You will work with internal customers and external vendors, ensuring CFR 21 Part 11 compliance and Celgene standards, under minimal supervision.

The role requires a BS degree with at least five years in FDA-regulated environments, strong documentation and cross-functional collaboration skills,

Qualifications

• 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 and 21 CFR Part 11 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 executing equipment qualification documents.
• Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups.
• 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.

Responsibilities

• Maintain and validate equipment and systems per CFR21 Part 11 and Celgene standards.
• Manage deviations, CAPA investigations, and issue resolution.
• Document configuration and qualification activities; supervise vendors.
• Own lifecycle deliverables for equipment qualification and CSV.
• Develop validation deliverables: plans, specs, protocols, traceability, reports.
• Lead projects within functional area; supervise team members.
• Provide training on procedures and best practices.
• Assist site qualification projects including scheduling, procurement, installation, turnover.
• Support standardization of validation deliverables review and approval.

Skills

cGXP knowledge

21 CFR Part 11

SDLC principles

Documentation

Communication

Cross-functional collaboration

MS Office

Project leadership

Education

BS degree or equivalent experience

Tools

MS Windows

Visio

Excel

Outlook

Job 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.

Position Summary

The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and 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.

Duties/Responsibilities

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures:

• 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 Celgene 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.

Promotes and provides excellent customer service and support.

• 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.

Regulatory Responsibilities

• Ensure equipment, facilities and programs are maintained in compliance.
• Act as departmental lead and SME in both internal and regulatory audits.

Qualifications

Knowledge/Skills/Abilities:

• 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 and 21 CFR Part 11 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 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.

Competencies

• Technical / Professional Knowledge
• Problem Solving / Troubleshooting
• Action Oriented
• Attention to Detail
• Multi-tasking
• Building Relationships

Education/Experience

• BS degree or equivalent experience
• Minimum 5 years of experience in FDA-regulated industry

Physical / Mental Demands

Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs. Ability to sit, stand, walk and move within workspace for extended periods. Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

Environmental Conditions

Primarily an office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes. Ability to work safely and effectively when working alone or working with others.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Compensation Overview

Summit West - NJ - US: $106,630 - $129,214
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where 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.

Supporting People with Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For 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/ For 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.

Data Protection

We 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1604099 : Manager, Computer System Validation (CSV) – Cell Therapy