Job Details

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 rich in diversity. 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.

Position Summary

The Senior Manager, Validation, Engineering and Technology is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at the Bristol Myers Squibb Manufacturing Plant (Jump), Bothell, WA. The Senior Manager oversees the Right to Operate, Operational Excellence and Ongoing Monitoring area within the Validation, Engineering & Technology (VET) team.

The Senior Manager will also oversee ad hoc teams performing VET activities, ensures the completion of all deliverables and develops the long term strategy of VET. Work will heavily involve the use and management of validation document control and quality system software and applications (e.g. ValGenesis, Infinity, Veeva Vault, Success Factors, BMRAM etc.), project plans and dashboards to drive accountability and delivery for the MSAT VET team.

This role will play a critical 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 leader with deep expertise in GMP, a thorough understanding of lab/manufacturing equipment, and a proven track record in validation processes.

Duties/Responsibilities

• Develop and execute validation plans for cGMP critical equipment and system with validation document deliverable in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and data integrity requirements.
• Act as a validation Subject Matter Expert (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.
• Lead/assist new facility and utility design, incorporation of new technology/processes/equipment, and/or upgrade current assets.
• Execute and/or lead multiple projects that require qualification work arising from change controls, risk assessment, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders and support GMP operations. On occasion, leads multiple technical teams and champions cross-functional projects and initiatives. 
• Work collaboratively with peers within the cross-functional teams (F&E, IT, MFG, QC, Supply Chain, and QA/QEV) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• Build, maintain and leverage relationships across the matrix to identify opportunities for process improvement and facilitate the implementation of measurement and management systems.
• Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests and maintain Jira system as part of the Agile methodology.
• Support GMSAT including our R&D site to execute validation related projects and make standardization across the sites. Develop and manage an ongoing monitoring program for GMP assets to ensure continued compliance and performance.
• Foster a culture of compliance, quality, and continuous improvement within the validation team.
• Interface with regulatory agencies during inspections and audits, serving as the subject matter expert for validation processes.
• Provide expert guidance and support to ensure that all validation processes and documentation meet regulatory expectations.
• 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 optimize processes and reduce validation cycle times while maintaining the highest quality.
• Ensure all validation documentation, including protocols, test scripts, and reports, are accurately completed, reviewed, and archived in accordance with company policies.
• Routinely seek opportunities to learn BMS values. Excel in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and work to address perceived deficiencies.

Qualifications

• Bachelor’s Degree in life sciences/engineering/STEM or equivalent
• 8+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries
• 4+ years of experience managing direct reports
• Expert 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/facility qualifications and general commissioning, qualification and validation practices are required.
• Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry are required.
• 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) documents through system retirement.
• Excellent 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.
• Possess the professionalism and technical competency required to represent the department before our 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 utilizing regulatory knowledge to drive innovation and improvement in validation and engineering functions.
• Lean and Six Sigma experience is desirable

The starting compensation for this job is a range from $114,000 - $144,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.

For more on benefits, please visit our BMS Careers site.

Eligibility for specific benefits listed in our careers site may vary based on the job and location.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

TRAVEL REQUIREMENTS:

☐ Not Applicable-NA

Infrequent visits to other BMS Cell Therapy sites and the Seattle, WA facility may be required.

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management within reason.

BMSCART VETERAN

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.

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 an inclusive culture, promoting diversity 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 a diverse 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.

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

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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