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Validation Engineer II

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Company :
Bristol-Myers Squibb

Location :
Bothell, Washington

Expiry Date :
Tue, 06 Apr 2021 23:59:59 GMT

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Description :
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through 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 AND SCOPE OF POSITION: The Validation Engineer II is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at the Bothell manufacturing plant. The Validation Engineer III oversees aseptic processing qualification and environmental control programs as a member of the site’s Manufacturing Sciences and Technology (MSAT) department. The Validation Engineer III will contribute and be responsible for representing Validation in cross-functional efforts to ensure patient safety and implement best in class practices. Responsibilities include, but are not limited to, the following: – Displaying an understanding and passion for cell therapy manufacturing. – Manage and lead a cross functional team responsible for aseptic processing and cleanroom qualifications. – Support cross-functional efforts to ensure regulatory compliance. – Overseeing the cleanroom lifecycle qualification program. – Overseeing the ongoing monitoring and maintenance of validated state in support of on-demand work in collaboration with facilities and quality functions. – Develop and manage validation documentation (e.g. procedures, protocols, studies, reports). – Support electronic documentation and validation systems (e.g. Veeva, Valgenesis) utilization for the MSAT Validation organization. – Interface with cross-functional team (e.g. Manufacturing, Quality, Training, Facilities and Engineering) and serve as validation SME. – Provide cross functional training over validation and qualification activities. – Support quality systems initiatives such as validation impact assessments. – Follow validation policies, procedures, and the validation master plan. – Provide strong technical knowledge of cellular therapy systems, materials, equipment, and aseptic processing techniques. – Coordinate department validation activities within the production schedule. – Support site validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV), Airflow Visualization Studies (AVS), Environmental Monitoring Performance Qualification (EMPQ). – Perform investigations associated to validation activities and deviations. – Perform data analysis, including the use of statistics, and prepare written reports/summaries from validation studies. – Provide technical input and investigation support for production related investigations, ensuring compliance with validated state of the process. – Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state. – Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records) ensuring compliance with validated state. – Interact with other teams including Process Engineering and Support, Development, Operations, QA and Regulatory. – Interface with regulatory authorities as required. – Stay current with industry trends, standards (e.g. PDA, ISPE), and participate in best practice forums consistent with function responsibilities. – Foster strong inter-team relationships to achieve common project goals. – Support the tracking of team metrics and manage completion of objectives and projects. – Actively participate and manage meetings. Leadership: – Create an environment of teamwork, open communication, and a sense of urgency – Support the change agent in promoting flexibility, creativity, and accountability – Support organizational strategic goals and objectives that are linked to the overall company strategy – Drive strong collaboration within the plant and across the network – Build trust and effective relationships with peers and stakeholders – Deliver business results through timely and quality decision making – Foster a culture of compliance and strong environmental, health, and safety performance – Promote a mindset of continuous improvement, innovation, problem solving, and contamination control – Demonstrate enthusiasm for serving patients and product quality REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: – Knowledge of cGMPs and multi-national biopharmaceutical/cell therapy regulations. – Knowledge of microbiology, aseptic processing, cleanroom qualification, facility, engineering, and contamination controls. – Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities. – Experience with single-use technologies and functionally closed systems. – Experience working with external parties and/or leading cross-functional teams. – Possess strong verbal, written communication skills, active listening skills, and ability to influence at all levels. – Ability to interpretate data and use sound science to drive decision-making. – Ability to prioritize and provide clear direction to team members in a highly dynamic environment. – Experience with Operational Excellence and Lean Manufacturing. Education and Experience: – Bachelors Degree in Life Sciences, Engineering or equivalent – 5+ years of experience in the biotech or biopharmaceutical industry – Experience leading small teams and projects – Experience in the cell therapy industry WORKING CONDITIONS (US Only): This position involves work to be performed in controlled and classified environments where personnel are required to demonstrate good aseptic behaviors (e.g. aseptic practices, donning cleanroom garments, decontaminating materials and equipment). This positions also requires physical activities such as lifting and transporting of equipment (~50 lbs) and extended hours (> 2 hours) of sitting, standing, walking in a cleanroom environment. 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. Around 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. BMSCART Around 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. 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 any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.