Automation Engineer II, Cell Therapy

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.

The Automation Engineer CAR-T is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Process Automation Engineer is responsible for performing qualification and validation activities for GxP computerized systems while considering industry best practices. He/She collaborates with SME from the Process Engineering & Support, Manufacturing Group, and Quality Group to ensure automation requirements are satisfied in support of the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities include, but are not limited to, the following:
• Ensure safe and compliant cGMP operations
• Maintain permanent inspection readiness and actively support regulatory inspections.
• Uses standard systems, policies and procedures required for implementation, qualification
and validation of computerized systems.
• Support development of life cycle documents and system requirements. Design the
validation approach with technical oversight, provide the scientific rationale and acceptance
criteria and generate validation protocols.
• Execute qualification activities with oversight, execute CAPA plans, risk assessments,
investigations and root cause analysis.
• Support change initiatives and the implementation of process improvement initiatives by
assessing the impact to the validated state of the automation.
• Review and revise the content of technical documentation (e.g. investigations, changes, SOPs
and batch records) ensuring compliance with validated state of the automation.
• Interface with regulatory authorities as required to support Manufacturing Operations audits.
• Stay current with industry trends and 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.

REQUIRED COMPETENCIES:

Education and Experience:
• Bachelor's Degree required (science or engineering is preferred)
• 4 or more years of manufacturing support or related experience in the biopharmaceutical industry

Knowledge, Skills, and Abilities:
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
• Foster a culture of compliance and strong environmental, health, and safety performance
• Promote a mindset of continuous improvement, problem solving, and prevention

Skills/Knowledge Required:
• Knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations
• Deep knowledge of equipment, automation, and validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical
manufacturing facilities
• Possess strong verbal/written communication skills and ability to influence at all levels
• Experience with Operational Excellence and Lean Manufacturing

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.