Within this role you will be responsible for the design and configuration of the Manufacturing Execution Systems (MES) manufacturing batch records and equipment data. The successful individual is responsible for eliciting and documenting manufacturing business processes requirements.
As a MES Operations Analyst, a typical day might include, but is not limited to, the following:
* Designing and deploying MES system (Werum’s PAS-X) to replace paper-based processes or manual processes in the processing areas.
* Coordinating the needs of functional departments and establishing priorities for MES user requirements gathering, system design, and implementation.
* Participating in project deliverables such as review of company documentation including SOPs, Batch Sheets, and/or Manufacturing Records to assess requirements for designing electronic records.
* Designing and developing MES recipes, workflows, equipment, master data, and electronic batch records to meet the requirements of the Business, specifically Manufacturing and QA.
* Participating in the creation and testing of MES-related protocols.
* Maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle.
* Processing system change control, documenting configuration, and writing test plans to ensure that the MES remains in a validated state.
* Liaising with Technical Trainers to develop training plans for MES users.
* Providing end-user support for the MES including troubleshooting problems on the floor and working closely with IT to troubleshoot problems.
* Implementing strategies to improve process efficiencies.
This role might be for you if:
* You demonstrate knowledge and experience of MES preferably Werum PAS/X.
* You possess logical troubleshooting and problem-solving skills.
* You have excellent analytical, written, and oral communication skills.
* You demonstrate an ability to work within a successful team.
To be considered for this opportunity, you should have a BS/BA/BEng in a technical discipline, with 0-2 years of experience working within a Life Sciences manufacturing environment or an equivalent combination of education and experience.
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