Senior Engineer I, Validation

Bristol Myers Squibb EU Policy; Bothell (WA); On-site; USD 107,000 - 130,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well‑being

Paid Time Off

Job summary

Bristol Myers Squibb in Bothell, WA seeks a Senior Engineer I, Validation to lead commissioning, qualification and validation (CQV) activities for GMP operations. You will work with cross‑functional teams including Facilities, IT, Manufacturing and QA, ensuring IQ/OQ/PQ deliverables meet regulatory requirements.

The role requires 5+ years CQV experience, strong knowledge of cGMP and CSV, and excellent project management and technical writing skills.

Qualifications

• 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 and general commissioning, qualification and validation CQV practices.
• Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry is beneficial.
• Experience and in-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (URS to IQ/OQ/PQ and CSV).
• Excellent project and programme management, communication and technical writing skills.
• Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents.
• Possess the professionalism and technical competency to represent the department before customers, regulatory agencies and management.
• Experience in the Pharma / Biopharma required; cell therapy industry is a plus.
• Detail oriented, with strong GMP, validation and engineering experience.
• Experience utilising regulatory knowledge to drive innovation and improvement in validation and engineering functions.

Responsibilities

• Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
• Acts as a validation SME providing support to multi‑function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
• Executes multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders.
• Work collaboratively with peers within the cross‑functional teams to manage workload, address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
• Regularly reviews, prioritises, and promptly responds to customer equipment qualification and support requests.
• Routinely seeks opportunities to learn BMS values and demonstrates them.
• 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, serving as the subject matter expert for validation processes.
• Collaborate with cross‑functional teams to address any findings related to validation and implement corrective actions as necessary.
• Oversee the qualification and validation of laboratory instruments, equipment, and systems, including analytics, autoclaves and environmental monitoring systems.
• Implement risk‑based validation approaches to optimise processes and reduce validation cycle times while maintaining quality.
• Identify opportunities for process optimisation and efficiency improvements within the validation function.
• Develop and deliver training programmes for validation team members.

Skills

CQV experience

cGMP knowledge

Project management

Technical writing

Quality systems

Education

Bachelor’s Degree in life sciences, engineering, STEM or equivalent years of experience

Tools

CSV (Computer System Validation)

URS/IQ/OQ/PQ lifecycle

Electronic document management systems

Job description

Working with Us

Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Duties / Responsibilities

• Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
• Acts as a validation SME providing support to multi‑function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
• Executes multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders.
• Work collaboratively with peers within the cross‑functional teams (Facilities and Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance and Quality Engineering Validation) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
• Regularly reviews, prioritises, and promptly responds to customer equipment qualification and support requests.
• Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.
• Routinely seeks opportunities to learn BMS values. Excels in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and works 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, serving as the subject matter expert for validation processes.
• Collaborate with cross‑functional teams to address any findings related to validation and implement corrective actions as necessary.
• Oversee the qualification and validation of laboratory instruments, equipment, and systems, including but not limited to analytical instruments, autoclaves and environmental monitoring systems.
• Implement risk‑based validation approaches to optimise processes and reduce validation cycle times while maintaining the highest quality.
• Identify opportunities for process optimisation and efficiency improvements within the validation function, collaborating with cross‑functional teams as needed.
• Develop and deliver training programmes for validation team members to enhance their capabilities and knowledge of validation principles and practices.

Qualifications

• 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 and general commissioning, qualification and validation CQV practices.
• Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry is beneficial.
• Experience and in‑depth understanding 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.
• Excellent project and programme management, communication and technical writing skills.
• Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents.
• Possess the professionalism and technical competency required to represent the department before customers, regulatory agencies and management.
• Experience in the Pharma / Biopharma required, cell therapy industry is plus.
• Detail oriented, with strong GMP, validation and engineering experience.
• Experience utilising regulatory knowledge to drive innovation and improvement in validation and engineering functions.

Compensation Overview

Bothell - WA - US: $107,000 - $129,656

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

• 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 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.

Uniquely Interesting Work, Life‑changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On‑site Protocol

BMS Has An Occupancy Structure That Determines Where An Employee Is Required To Conduct Their Work. This Structure Includes Site‑essential, Site‑by‑design, Field‑based And Remote‑by‑design Jobs. The Occupancy Type That You Are Assigned Is Determined By The Nature And Responsibilities Of Your Role:

• Site‑essential roles require 100% of shifts onsite at your assigned facility.
• Site‑by‑design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
• For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity and a positive company culture.
• For field‑based and remote‑by‑design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation or adjustment prior to accepting a job offer. If you require reasonable accommodations or adjustments in completing this application, or in any part of the recruitment process, direct your enquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

Data Protection

We will never request payments, financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1605031 : Senior Engineer I, Validation