Senior Engineer I, Validation - Bristol Myers Squibb

**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 Sr. Engineer I, Validation is a skilled engineer who is responsible for validation support to the production of personalized cell therapy products for both global clinical trials and commercial supply at the Bristol Myers Squibb, Bothell, WA. The Sr. Engineer I, Validation will be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring compliance during validation activities. This includes developing and delivering GMP equipment, facilities, and utilities validation programs to ensure compliance with applicable cGMPs and global health authority regulations. The Sr. Engineer I, Validation will partner with cross-functional teams to develop validation plans and ensure their execution and lifecycle management. **Duties/Responsibilities** The Sr. Engineer I, Validation 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. + Develops and executes validation plan 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. + Establish validation protocols, risk assessments, and qualification plans to support GMP operations. + Acts 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. + Executes and/or leads 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. + Leads teams with specialized focus on strategic validation projects to evolve the organization. With some frequency, makes an impact on the broader validation team. + Regularly reviews, prioritizes, 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. + Support Global MSAT 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. + 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. + Act as the primary point of contact for validation-related inquiries during regulatory inspections and audits. + 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. + Identify opportunities for process optimization and efficiency improvements within the validation function, collaborating with cross-functional teams as needed. + Develop and deliver training programs 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 + 5+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries + 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 CQV 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) and computer system validation (CSV) 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. The starting compensation for this job is a range from $92,000 to $121,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 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 our BMS Careers Site (https://careers.bms.com/working-with-us) . 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. BMSCART 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/ (https://careers.bms.com/eeo-accessibility) 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. 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/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1584244 **Updated:** 2024-09-21 04:37:19.253 UTC **Location:** Bothell-WA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.