The Validation Associate Engineer will play a significant role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on individual with experience in GMP, an understanding of laboratory and/or manufacturing equipment, and strong technical writing and problem solving skills. Key Responsibilities • Support the Periodic Review and Periodic Requalification program at BMS sites in Bothell, WA and Seattle, WA, including execution of requalification activities (temperature mapping studies), and development of Periodic Reviews. • With oversight, generate validation protocols, specifications, reports, and qualification plans to support GMP operations. • Perform Validation Impact Assessments for on demand work orders of qualified equipment, utilities, and facilities. • Supports execution of projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans under direction of a more senior Validation Engineer. • Work collaboratively with peers within the cross-functional teams (Facilities and Engineering, Information Technology, Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation) to support projects and qualification work. • Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other Validation team members and helps them to be successful. • Routinely seeks opportunities to learn and practice BMS values. Demonstrates the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, and Accountability) and works to address perceived deficiencies. Qualifications & Experience • Bachelor's Degree in life sciences/engineering/STEM or equivalent • 2 years of experience in a GMP setting, preferably pharmaceutical manufacturing operations or support. • Experience or exposure with commissioning, qualification, and validation (CQV) within technical and regulated industries is recommended. • Awareness 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/facility qualifications and general commissioning, qualification and validation CQV practices is beneficial. • Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry is beneficial. • Experience of validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ and SR) and computer system validation (CSV) documents through system retirement is beneficial. • Strong project and program management, communication skills, and technical writing skills are required. • Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Bothell - WA - US: $83,220 - $100,847 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: • 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. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. R1604052 : Validation Associate Engineer