Electronic Batch Record Recipe Author
- The Recipe Author shall develop new Electronic Batch Records (eBRs) and revise existing eBRs using a library of existing work instructions and operations including creation of complex process recipes.
- Translate business requirements into a robust eBR design which is compliant, efficient, and effective.
- Coordinate the user acceptance testing of MES recipes with peers and internal customers to ensure business requirements are achieved.
- Develop validation test cases and perform testing (IQ,OQ, PQ).
- Develop and provide operational and technical training.
- Train site users/Business SMEs.
- The MES Recipe Author shall provide technical and functional support to User group on addressing day to day production issues
- Provide periodic on-call support to internal customers for emergency system issues.
- Troubleshoot routine and complex problems to support internal customers.
- Test, validate and demonstrate Master Recipes.
- Assist in designing, testing, and maintaining the electronic batch record (EBR) MES Recipes and related Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
- Maintain the recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable electronic batch records and supporting data.
- Develop and execute change controls and master data change requests for master data and MES Recipe configuration changes.
- Develop system technical documentation; including but not limited to, functional specifications and UAT test scripts.
- Provide department representation on site projects
- Collaborate among peers and internal customers to determine system business requirements.
- Assist and Lead training efforts for Manufacturing associates, supervisors, and Quality personnel.
- Create, Assess and/or review deviations and change controls
- Assist in the building of task durations and overall schedule
- Understand current requirements and schedule for completion
- Balance multiple requirements to meet schedule expectations
- Elevate concerns of schedule slip prior to the delivery date
- Authoring planned and unplanned deviations including CAPAs (Corrective and Preventative Actions)
- Closing all assigned quality docs in a timely manner
- Participation in after-hours production support is required via a rotating on-call schedule
- Co-ordinate with Product Vendor in presenting incidents and follow-up in getting solutions
- Responsible for Recipe Version Controls
- Stress the importance of safety/quality & delivery and develop an environment of continuous improvement.
- Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.
- Bachelor’s degree preferred
- Minimum 3 years of experience in Pharmaceuticals Industry.
- Certificate/ASC/ BS in science-related discipline preferred.
- Excellent Communication Skills.
- Hands on experience with manufacturing execution systems (MES) such as Rockwell Automation PharmaSuite or similar MES Systems.