Lead Process Systems Engineer, Cell Therapy
2 weeks ago
At Bristol Myers Squibb, we are committed to making a difference in the lives of patients through innovative work that is both challenging and rewarding. Our diverse teams engage in meaningful projects that have a real impact on healthcare.
Position Overview:
The Senior Engineer, Process Systems is responsible for contributing to the design and development of electronic Process Systems, including DeltaV, OSI Pi, electronic batch records (MES), and process monitoring systems. This role involves collaboration with various departments such as Digital Plant, IT, and Manufacturing Operations to implement process changes effectively.
Key Responsibilities:
- Utilize manufacturing process expertise and technical knowledge of process systems during change management initiatives.
- Revise Functional Specifications for process systems, ensuring compliance with governing documents related to change management.
- Collaborate with cross-functional teams, including Manufacturing, Digital Plant, IT, Validation, Quality, and MSAT, to drive change initiatives to completion.
- Oversee the lifecycle of process system modifications.
- Engage with site functional teams to gather user requirements for development of changes.
- Possess a strong understanding of DeltaV and MES library objects to guide changes in associated systems.
- Create documentation to support the qualification of DeltaV and MES recipes, including test scripts and functional specifications.
- Conduct testing of changes in the development environment to ensure proper functionality.
- Generate reports or metrics from reporting software.
- Employ creative problem-solving techniques.
- Provide technical support for manufacturing operations, investigations, and change controls as a subject matter expert in process systems.
- Foster collaboration within the plant and across the network.
- Build effective relationships with peers and stakeholders.
- Perform additional tasks as assigned.
- Bachelor's Degree in a relevant field from an accredited institution (preferably in science or engineering).
- A minimum of 2 years of relevant experience, ideally in the pharmaceutical, biotechnology, or cell therapy manufacturing sectors.
- Familiarity with DeltaV, Syncade MES, or other process automation systems is highly desirable.
- Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is essential.
- Strong project management skills are required, with at least 1 year of experience in project coordination and cross-functional team leadership preferred.
- At least 1 year of experience supporting Delta V, Syncade MES, or other process automation software is advantageous.
- Access to classified manufacturing areas requires appropriate gowning.
- Flexibility to work extended hours or modified schedules as necessary for 24/7 manufacturing operations.
This job description outlines the general nature and level of work performed by the individual in this position. It is not intended to be an exhaustive list of all responsibilities and duties associated with the role.
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