Senior Technical MES Lead
Senior Technical MES Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The project involves full integration with the Automation Layer and systems across Levels 3 and 4 of the ISA95 model.
The ideal candidates must meet the following qualifications:
- Over 1015 years of experience in MES/Automation execution within the Pharmaceutical Manufacturing Industry.
- Expertise in GMP requirements and compliance for complex MES solutions.
- Indepth knowledge of pharma manufacturing processes including filling compounding formulation OSD fractionation purification etc.
- Ability to translate manufacturing processes into MES solutions across various ISA95 layers ensuring proper data modeling and defining sources of truth.
- Proven experience with MES/Control systems integration (e.g. DeltaV FactoryTalk DCS etc.).
- Indepth understanding of SAP order management inventory and materials management modules with a focus on MES integration.
- Extensive experience in the design and implementation of MES software (e.g. Syncade PharmaSuite PMX PASX).
- Proficient in reviewing and troubleshooting recipes making necessary updates to meet client specifications.
- Familiarity with validation tools such as Kneat and HP ALM.
- Proven experience in developing MES validation strategies test scripts and execution plans.
- Track record of delivering MES training across all levels of the organization (e.g. operators supervisors quality teams).
- Ability to prioritize and work under aggressive schedules.
Additional responsibilities will include:
- Willingness to perform onsite visits at short notice including peripheral equipment integration support recipe dry runs execution and deployment.
- Providing technical direction for MES and integration design development and validation activities.
- Ensuring adherence to global standards including alignment with Thermo Fishers MES and IT frameworks.
- Effectively articulating technical issues and solutions for escalation to project sponsors or leadership teams.
- Independently drafting reviewing and updating SDLC documentation (e.g. URS Trace Matrix Test Scripts SOPs Change Logs) with minimal supervision.
- Leading customer reviews and dry runs of solutions acting as a liaison between site teams and Rockwell.
- Managing equipment configurations and connections including peripherals like scales and workstations.
- Verifying IT configurations such as ports and firewalls to ensure seamless integration.
- Leading the creation and implementation of a sitewide training program across different functional teams.
Employment Type
Full Time
