Overview
Skills
Job Details
Top 3 to 5 Skills/Must Haves:
Manufacturing or Process background
Electronic batch records
Project management skills
Validation experience is a plus
MES preferred
Purpose and Scope of the Position:
The Process Systems Engineer provides input to the design and development for electronic Process systems including electronic batch records (MES), DeltaV, OSI Pi, and process monitoring systems. The Engineer works with Digital Plant, IT, Manufacturing Operations, and process subject matter experts to deliver process Changes. The position requires excellent project management skills and coordination with stakeholders, as well as leadership, enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and a subject matter expert in process systems.
Duties and Responsibilities:
Apply manufacturing process expertise and process system technical knowledge during change management.
Own User Requirements for process systems. Ensure consistent execution of system modifications and changes. Ensure adherence with governing documents related to change management.
Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MSAT to ensure change initiatives are driven to closure and migrated to the production area in a timely manner.
Owns the lifecycle of process system changes.
Works with site functional teams, including manufacturing, engineering, warehouse, and quality assurance to gather user requirements for change development.
Understanding of DeltaV and MES library objects. Use that understanding to direct changes to associated systems.
Develop documentation to support the qualification of the DeltaV and MES recipes, including test scripts and User Requirements.
Execute testing of the changes in the development environment to ensure functionality.
Support Chain of Identity program and ensure it is maintained within the process systems.
Manage User Acceptance Testing process for system qualification.
Develop and deliver reports from reporting software.
Provide technical support for manufacturing operations, investigations and change controls as a process system subject matter expert.
Education:
Bachelor s Degree in a related field from an accredited college or university required (science or engineering preferred)
Experience:
Strong project management skills are needed. Minimum of 1 year of experience with project coordination and cross-functional team leadership preferred.
Minimum 1 year of experience support DeltaV, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.
Minimum 1 year of experience supporting electronic batch records, preferably Syncade MES.
5 or more years of relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.
Knowledge of DeltaV and process automation is required. Syncade MES is a plus.
Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is required.