Key responsibilities:
- Serve as a Subject Matter Expert (SME) of the site MES recipe/workflow process.
- Create and maintain MES master data.
- Collaborate with operations, Quality, Engineering, and other departments to support and maintain MES interfaces with automated functions (e.g., SAP, LIMS, Historian).
- Initiate, revise, and validate MES functions for operations; initiate/support validation documents required for operations.
- Support MES system functions relating to EBR recipes, workflows, and master data.
- Develop and/or revise MES procedures to comply with current GMPs and quality compliance.
- Support audits and periodic reviews of EBR recipes, workflows, and master data per company policies.
- Provide and support MES end user training in compliance with applicable procedures and regulations.
Minimum qualifications:
- Bachelorβs degree (or equivalent) and 2β4 years of relevant experience (combination of education/experience considered).
- Excellent verbal and written communication skills; ability to read/follow oral and written instructions; complete documentation.
- Computer literacy and technical abilities in writing and functional testing.
- Attention to detail and ability to interpret instructions in electronic records/manufacturing orders/procedures/qualification and/or validation protocols.
- Ability to perform arithmetic computations associated with the role.