Automation Engineer II Cell Therapy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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, qualificationand validation of computerized systems.

Support development of life cycle documents and system requirements. Design thevalidation approach with technical oversight, provide the scientific rationale and acceptancecriteria 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 byassessing the impact to the validated state of the automation.

Review and revise the content of technical documentation (e.g. investigations, changes, SOPsand 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 bestpractice 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 companystrategy

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 biopharmaceuticalmanufacturing facilities

Possess strong verbal/written communication skills and ability to influence at all levels

Experience with Operational Excellence and Lean ManufacturingBristol-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 the resources to pursue their goals, both at work and in their personal lives. Company: Bristol-Myers Squibb Req Number: R1520965_EN Updated: 2020-03-18 00:00:00.000 UTC Location: Summit,New Jersey

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com