Senior Specialist, Validation Engineer - CSV

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.

• 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 alignment with BMS directives and industry guidelines on validation.

• Knowledge of biopharmaceutical processing including a minimum of 2 years of experience developing and/or testing process automation system software (preferably Delta V batch). Experience with large scale distributed control systems desired.
• Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
• Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Understanding of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and know how to work and manage within a regulatory environment.
• DCS and PLC based experience, preferably gained in the pharmaceutical industry.
• Understanding of lean principles is a plus.
• Project management, communication, and technical writing skills are required.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

#LI-Onsite

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.

Devens - MA - US: $92,540 - $112,136

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…