Validation Senior Specialist

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 Cell Therapy Facility Senior Specialist supports the qualification and validation of a CAR-T facility, including facilities, critical utilities, processing equipment, and quality control laboratory. With some supervision and given general instructions, this individual carries out routine tasks and functions, and uses analytical skills to recognize and help to solve problems of various degrees of complexity and scope. As a developing team player, the incumbent interacts with their immediate supervisor and colleagues within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

The Senior Specialist, through hands-on leadership, will be directly responsible for individual efforts, projects and other tasks. The incumbent will be responsible for fostering a productive, learning environment for colleagues and reports while ensuring timely completion of assigned work.

Key Responsibilities:

• Performs equipment qualification and validation activities on various equipment/instruments and facility systems

• Develops validation/qualification deliverables such as Validation Protocols, Traceability Matrices, Summary Reports.

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

• Applies technical skillset to investigate and help to resolve complex challenges

• Investigate and resolve Validation Deviations, CAPA investigations and other potential issues

• Works with IT partners to ensure configuration and documentation of computerized systems to meet the requirements of CFR21 Part 11.

• Supervises vendors for qualification functions.

• Completes all qualification and validation documentation with accuracy, completeness and compliance to BMS standards.

• Responsible for the delivery of all lifecycle deliverables in the Qualification of facilities, utilities and equipment.

• 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.

• Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.

• Support growing standardization efforts in the review and approval of Validation Deliverables

• Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.

• Regularly reviews, prioritizes and promptly responds to customer qualification, validation and support requests.

• Support departmental delegates and Subject Matter Experts in both internal and regulatory audits.

Education & Experience:

• Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience

• Minimum 4 years of experience in FDA-regulated industry

• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry. Able to act as a resource for colleagues.

• Knowledge of ISPE C&Q guidance and 21 CFR Part 11 compliance

• Technical writing capability and experience with writing, approving and training staff on SOPs and validation documents

Knowledge, Skills & Abilities:

• Knowledge of pharmaceutical laboratory and manufacturing systems.

• Experience authoring and executing standard C&Q deliverables

• Ability to interact effectively with manufacturing, automation/IT, laboratory, QA, and Facilities groups

• 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 qualifications

• Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.

#LI-Onsite

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.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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