Senior Engineer I, Validation

About the role

Working at Bristol Myers Squibb is challenging, meaningful, and life-changing. Here, uniquely interesting work happens every day, transforming the lives of patients and the careers of those who do it. You’ll grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Bristol Myers Squibb recognizes the importance of balance and flexibility, offering a wide variety of competitive benefits, services, and programs to support employees in pursuing their goals both at work and in their personal lives.

Responsibilities

• Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
• Act as a validation Subject Matter Expert (SME), providing support to multi-function teams, advising operations on validation matters, and serving as the point of contact for validation programs and strategies during Health Authority inspections and audits.
• Execute multiple projects requiring qualification work from change controls, capital projects, and ongoing supplemental validation deliverables per approved validation plans as the point of contact for project stakeholders.
• Collaborate with cross-functional teams (Facilities and Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation) to manage workload, address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• With minimal supervision, execute validation projects and tasks, occasionally leading one or more projects within the validation area and contributing to broader site initiatives.
• Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests.
• Proactively support team members, helping them succeed and stepping up to learn from others.
• Demonstrate BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and work to address perceived deficiencies.
• Foster a culture of compliance, quality, and continuous improvement within the validation team.
• Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations remain in full compliance.
• Interface with regulatory agencies during inspections and audits as the subject matter expert for validation processes.
• Collaborate with cross-functional teams to address findings related to validation and implement corrective actions.
• Oversee the qualification and validation of laboratory instruments, equipment, and systems, including analytical instruments, autoclaves, and environmental monitoring systems.
• Implement risk-based validation approaches to optimize processes and reduce validation cycle times while maintaining the highest quality.
• Identify opportunities for process optimization and efficiency improvements within the validation function.
• Develop and deliver training programs for validation team members to enhance their capabilities and knowledge of validation principles and practices.

Requirements

• Bachelor’s Degree in life sciences, engineering, STEM, or equivalent years of experience.
• 5+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries.
• Robust knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements.
• Experience with equipment, utility, and facility qualifications, as well as general commissioning, qualification, and validation (CQV) practices.
• Experience with investigations, deviations, and CAPA management in a regulated pharmaceutical industry is beneficial.
• In-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (URS, IQ/OQ/PQ, and SR) and computer system validation (CSV) through system retirement.
• Excellent project and program management, communication skills, and technical writing skills.
• Knowledge and experience with electronic document management systems for quality records, procedural documents, and validation lifecycle documents are desired.
• Professionalism and technical competency to represent the department before customers, regulatory agencies, and management.
• Experience in the Pharma/Biopharma industry required; cell therapy industry is a plus.
• Detail-oriented with strong GMP, validation, and engineering experience.
• Experience utilizing regulatory knowledge to drive innovation and improvement in validation and engineering functions.

Pay

Bothell, WA, US: $107,000 - $129,656. The starting compensation range is for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate considers required skills, job location, work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

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:
  • 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).
    • 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.
  • Additional time off 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 Year’s Day (eligibility applies).