Bristol Myers Squibb Company

Automation Engineer I

Location
Summit West, NJ, United States
Posted
Sep 09, 2020
Ref
R1528498
Required Education
Bachelors Degree
Position Type
Full time
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 AND SCOPE OF POSITION:

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.

Duties and Responsibilities:

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.
  • Support development of 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.
  • 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, 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
  • Knowledge of equipment, automation, and validation
  • Exposure and understanding 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
  • Knowledge of Operational Excellence and Lean Manufacturing


Education and Experience:
  • Bachelor's Degree required (science or engineering is preferred)
  • 3 - 5 years of manufacturing support or related experience in the biopharmaceutical industry


WORKING CONDITIONS (US Only):

CAR T Automation Engineers will often work in a team environment with other professionals and may be in a position where they will be supervising staff/contractors. Also, CAR T Automation Engineers generally work in an office environment, however trips to the manufacturing areas and remote sites are required. For this reason, CAR T Automation Engineers must have the:
  • Ability to perform physical maintenance tasks with strength and mobility on process automation equipment, instrumentation, mechanical components, etc.
  • Ability to walk and occasionally lift heavy process automation equipment, instrumentation, mechanical components, etc.
  • Ability to stand for extended periods of time observing and troubleshooting process automation equipment, instrumentation, mechanical components, etc.
  • Ability to work in areas where posted Universal Precautions must be observed and practiced
  • Ability to work daily with potentially harmful and/or hazardous agents including blood borne pathogens, asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.


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.