What are the responsibilities and job description for the Sr Technical MES Lead position at Pacific Consultancy Services?
Job Details
Title: Sr Technical MES Lead
Location : Greenville, NC (Hybrid)
Description:
The ideal candidates must meet the following qualifications:
- Over 10-12 years of experience in MES/Automation execution within the pharmaceutical manufacturing industry.
- Expertise in GMP requirements and compliance for complex MES solutions.
- In-depth knowledge of pharma manufacturing processes including filling, compounding, formulation, OSD, fractionation, purification, etc.
- Ability to translate manufacturing processes into MES solutions across various ISA-95 layers, ensuring proper data modeling and defining sources of truth.
- Proven experience with MES/Control systems integration (e.g., DeltaV, FactoryTalk, DCS, etc.).
- In-depth 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, PAS-X).
- 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 on-site 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 Fisher's 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 site-wide training program across different functional teams.
Thanks regards..!
Siva Reddy
: 1( -EXT: 111)
Linkedin ID:-
: Shiva
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