Senior Technical MES Lead with Pharmaceutical
Senior Technical MES Lead with Pharmaceutical
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Hello;
Senior Technical MES Lead with Pharmaceutical Manufacturing Industry. Experience
Job Location: Greenville NC (Candidates needs to work 3 Days at the Client OfficeTuesday Wednesday and Thursday)
Long Term
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
