Bristol - Myers Squibb

The Senior Engineer I, Validation is responsible for supporting the production of personalized cell therapy products for clinical and commercial supply at the BMS Manufacturing Plant (Jump), in Bothell, WA. The Senior Engineer I, Validation is responsible for ensuring the compliance of aseptic processes and environmental control systems.. The Senior Engineer I, Validation supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs as a member of the Jump Manufacturing Sciences and Technology (MSAT) department.. Plan APS, AVS, CRC, EMPQ, and NRS aseptic and environmental control activities and coordinate cross-functional teams comprised of Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control, and Validation. 4+ years of experience in the biotechnology, biopharmaceutical, or cell therapy industry. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.

senior validation engineer

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 Engineer I, Validation is responsible for supporting the production of personalized cell therapy products for clinical and commercial supply at the BMS Manufacturing Plant (Jump), in Bothell, WA. The Senior Engineer I, Validation is responsible for ensuring the compliance of aseptic processes and environmental control systems. The Senior Engineer I, Validation supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs as a member of the Jump Manufacturing Sciences and Technology (MSAT) department. This role involves developing and executing validation protocols, as well as providing technical expertise and guidance to ensure the highest level of quality and regulatory compliance to ensure patient safety and implement best in class practices. Duties/Responsibilities <ul><li>Develops and executes validation plan for cGMP critical equipment and system with validation document deliverable in respect to cGMP, GDP, GXP, including 21CFR Part 11, , EU GMP Annex 1 principles.</li><li>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.</li><li>Develop, execute, and report on APS, AVS, CRC, EMPQ, and NRS aseptic and environmental control activities and manage requalification schedule for routine APS and CRC</li><li>Plan APS, AVS, CRC, EMPQ, and NRS aseptic and environmental control activities and coordinate cross-functional teams comprised of Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control, and Validation</li><li>Investigate and resolve deviations and non-conformances with oversight from Validation and Quality Assurance leadership</li><li>Maintain accurate and up-to-date validation documentation, including protocols, reports, and standard operating procedures (SOPs), in compliance with regulatory standards</li><li>Develop and manage electronic validation documentation such as risk assessments, protocols, studies, and reports using the ValGenesis validation lifecycle information management system</li><li>Serve as a subject matter expert for aseptic and environmental control programs</li><li>Support quality record processing through assisting in impact assessments and owning action items</li><li>Provide oversight, training, and support to APS, AVS, CRC, EMPQ, and NRS participants during aseptic and environmental control activities</li><li>Support cross-functional efforts to ensure regulatory compliance and protect patient safety</li><li>Follow validation regulations, policies, standards, procedures, and work instructions</li><li>Provide strong technical knowledge of cellular therapy systems, materials, equipment, and aseptic processing techniques</li><li>Provide technical input and investigation support for production related investigations to maintain the validated state of the aseptic process</li><li>Stay current with industry standards and participate in best practice forums consistent with function responsibilities</li><li>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.</li><li>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.</li><li>Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.</li><li>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.</li><li>Support GMSAT to execute validation related projects and make standardization across the sites. </li></ul>Reporting Relationship This position will report to the Associate Director| Validation, Engineering & Technology (VET), MSAT Qualifications <ul><li>Bachelor’s Degree in life sciences/engineering/STEM or equivalent</li><li>4+ years of experience in the biotechnology, biopharmaceutical, or cell therapy industry</li><li>Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements</li><li>Experience leading small teams and projects</li><li>Strong Knowledge of cGMPs and multi-national regulations, related to aseptic processes and environmental control systems</li><li>Knowledge of microbiology, aseptic processing, and facility qualification</li><li>Knowledge of facility, engineering, and contamination controls</li><li>Experience with the development, validation, and licensure of new biopharmaceutical manufacturing facilities</li><li>Experience with validation methodologies, including IQ,OQ, and PQ, as well as risk assessment tools.</li><li>Experience with single-use sterile technologies and closed systems</li><li>Experience working with external parties and leading cross-functional teams</li><li>Ability to interpret data and use sound science to drive decision-making</li><li>Ability to prioritize and provide clear direction to team members in a highly dynamic environment</li><li>Excellent project and program management, communication skills, and technical writing skills are required.</li><li>Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired.</li><li>Possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.</li><li>Experience in the Pharma/Biopharma required, cell therapy industry is plus.</li><li>Detail oriented, with strong GMP, Validation and Engineering experience</li><li>Experience utilizing regulatory knowledge to drive innovation and improvement in validation and engineering functions. </li></ul>The starting compensation for this job is a range from $92,000 - $115,000, 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. 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. 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. 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.

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