Senior Specialist, Validation Engineer - CSV

About the role

Principle Objective of Position: Qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (MES), which support clinical and commercial manufacturing facilities. Manage protocol generation, test execution, issue resolution and approval of qualification efforts to assure readiness for intended use to meet policy and compliance requirements. 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. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. 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.

Responsibilities

• Executes the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility.
• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).
• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
• Performs assessment of validation work and executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
• Executes technical work assignments as a point of contact for project stakeholders.
• Provides validation support, to multi-function teams, and advises operations on validation matters.
• Ensures