Specialist, Manufacturing Systems Validation, MS&T MSEO

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.

At Bristol Myers Squibb we are reimagining the future of Cell Therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant BMS procedures, such as CSV SOP but no limited and applicable health authority regulations.

Responsibilities:

• Review & approve S12 MES Next Gen related qualification & validation documentation.
• Work with BO, MES IT, and QA to ensure that the site validation documentation is created, reviewed, and approved appropriately.
• Assist BO & MES IT in installing updated recipes and E-MES quailed recipe-related components (e.g., Operations, Behaviors, Interfaces, Equipment Classes, Reports, etc.) to the S12 site and verifying compliance with CSV.
• Work with QA to ensure CSV validation deliverables are prepared without compliance issues.
• Provide CSV & validation Production and Project support to S12 MES Next Gen.
• Complete all tasks required per the Change Management Process for S12 MES Next Gen SOP and in compliance with CSV and related SOPs.
• Review the summary reports from testing/validation to ensure all issues are resolved and approved.
• Ensuring that risks and issues impacting the validation strategy are resolved and mitigated.
• Assist UAT Test Script authoring, execution, and defects closure.
• Support IQ Test Script authoring, reviewing, and pre & post approvals of execution and defects closure.
• Author the verification/validation related documents (e.g., Validation/Test Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/UAT], Summary Reports, Trace Matrices, SOPs, but not limited).
• Maintain the documents/testing trackers to support the needs of the Leader team.

Knowledge & Skills:

• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
• Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation.
• Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
• Understanding the concept of Critical thinking for Computerized Systems.
• Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs).
• Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods.
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