Bristol Myers Squibb: Cell Therapy Validation Engineer

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Purpose of the Position:The Cell Therapy Facility Validation Engineer supports the qualification and validation of a CAR-T facility, including facilities, critical utilities, processing equipment, and quality control laboratory. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses strong analytical skills to recognize and solve challenging problems of various degrees of complexity and scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.The Validation Engineer, through hands-on leadership, will be directly responsible for individual efforts, projects and other tasks. The incumbent will be responsible for fostering a productive, learning environment for colleagues and reports while ensuring timely completion of assigned work. Essential Functions:Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation strategiesDevelops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.Applies strong technical skillset to investigate and resolve complex challenges.Investigate and resolve Validation Deviations, CAPA investigations and other potential issuesWorks with Automation/IT partners to ensure configuration and documentation of computerized systems to meet the requirements of CFR21 Part 11.Supervises vendors for qualification functions.Completes all qualification and validation documentation with accuracy, completeness and compliance to BMS standards.Responsible for the delivery of all lifecycle deliverables in the Qualification of facilities, utilities and equipment.Initiates, manages and leads projects of moderate scope and complexity within their functional area.Provide direction and leadership to other team members to ensure completion of objectives.Manages projects of varying scope and complexity.Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.Author quality procedures and training documentsDeliver training on procedures and best practice to an audience that may include departmental personnel and business partners.Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.Support growing standardization efforts in the review and approval of Validation DeliverablesMaintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.Regularly reviews, prioritizes and promptly responds to customer qualification, validation and support requests.Provides technical support and guidance on Validation, Quality Process and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.Act as departmental delegate and SME in both internal and regulatory audits. Education & Experience:Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experienceMinimum 5 years of experience in FDA-regulated industryStrong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry. Able to act as a resource for colleagues.Strong knowledge of ISPE C& Q guidance and 21 CFR Part 11 complianceTechnical writing capability and experience with writing, approving and training staff on SOPs and validation documents Knowledge, Skills & Abilities:Strong working knowledge of MS Windows client and server technologies including user groups, folder permissions and windows policies is preferred.Ability to learn new technologies while applying a strong technical skillset to configure computerized systems to meet Business and Regulatory requirements.Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts.Ability to work with the end user to identify and document User and Functional RequirementsKnowledge of pharmaceutical laboratory and manufacturing systems.Experience authoring and executing standard C& Q deliverablesAbility to interact effectively with manufacturing, automation/IT, laboratory, QA, and Facilities groupsStrong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneouslyStrong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generationStrong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualificationsDemonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures. Working Conditions:Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbsAbility to sit, stand, walk and move within workspace for extended periodsAbility to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.Primarily an office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.Ability to work in the vicinity of strong magnets. BMSBL, BMSBLDMAAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.Bms.Com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.