Equipment Validation Engineer

Bristol Myers Squibb • Bothell, WA

3d • Onsite

About The Position

The New Product Introduction (NPI) Engineer – Equipment Validation is responsible for supporting and executing equipment validation activities to support the successful introduction of new products into manufacturing. This role ensures that production and test equipment are properly specified, installed, qualified, and validated in compliance with internal procedures, quality system requirements, and applicable regulatory standards. The NPI Engineer partners cross-functionally with R&D, Manufacturing, Quality, and Suppliers to drive robust validation strategies, mitigate risk, and ensure equipment readiness for launch, scale-up, and sustained production.

Requirements

• Bachelor’s degree in engineering, automation, or related scientific discipline.
• Three years or more of relevant experience.
• Skilled in preparing clear and effective technical documentation.
• Hands-on experience conducting or supporting risk assessments, such as Preliminary Hazard Analysis (PHA) or Failure Modes and Effects Analysis (FMEA).
• Demonstrated background in installing, operating, and troubleshooting Manufacturing and Quality Control equipment.
• Knowledge of single-use assembly applications within manufacturing.
• Experience collaborating with external vendors or suppliers to coordinate equipment projects.
• Strong analytical and problem-solving abilities, with a proven track record of working well in collaborative team settings.
• Excellent verbal and written communication skills, with an ability to build positive working relationships.
• Familiarity with Good Manufacturing Practices (GMP) and a solid understanding of relevant regulatory standards.

Nice To Haves

• Background in the biotechnology sector.

Responsibilities

• Work closely with internal Manufacturing, Quality Control, and Equipment Validation teams, as well as external partners, to help guide equipment design and development.
• Review a range of technical documents, including User Requirements Specifications (URS), equipment manuals, technical drawings, specifications, and validation protocols.
• Participate in risk assessment processes, such as Preliminary Hazard Analysis (PHA) and Failure Modes and Effects Analysis (FMEA), to ensure new equipment meets safety and reliability standards.
• Develop expertise in the user requirements for new equipment and continuously verify that Filler design remains consistent with those requirements throughout the project.
• Provide input to multiple Filler design elements, including single-use assembly integration and function, chassis configuration, and supporting infrastructure.
• Support the creation of a contamination control strategy for the Filler and ensure aseptic filling designs are in line with contamination prevention goals.
• Conduct proof-of-concept laboratory experiments as needed to assess equipment performance and functionality.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level