Senior Specialist, Validation Engineer II

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.

The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity.

With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited 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.

• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports
• Ensure periodic reviews and requalification is being performed in accordance with schedule.
• Supports equipment qualification and validation activities.
• Develops qualification protocols, and associated reports while adhering to a change management process.
• Author and review the Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.
• Responsibilities include execution of validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs, if necessary.
• Execute work arising from change strategy, risk assessment, testing and compliance gaps.
• Executes portfolio of limited scope and complex validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
• Maintains familiarity on BMS directives and industry guidelines on qualification/validation.
• Promotes and provides excellent customer service and support Regularly reviews, prioritizes, and promptly responds to end user equipment qualification and support requests.
• Provides technical support and guidance on qualification and validations issues.
• Interfaces with customers to ensure all expectations are being met.
• Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
• Contributes to multi-function teams, representing validation.
• Regulatory Responsibilities Ensure alignment with BMS directives and industry guidelines on validation and quality engineering.
• May be called upon as SME in both internal and regulatory audits.
• Responsible to contribute to the preparation for regulatory inspection readiness.
• Performs other duties as assigned.

Familiarity of cGMP in the pharmaceutical industry. Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred. Knowledge of distributed control systems and automation (GAMP) validation concepts suggested. Knowledge in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics / cell therapy manufacturing facility.

Familiarity of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing. A working understanding of lean principles and six sigma process is preferred. Demonstrated high proficiency in project…