Urgent C2C Jobs: Technical MES Lead with Pharma Manufacturing Industry Greenville, NC

Role: Senior Technical MES Lead with Pharmaceutical Manufacturing Industry

Location: Greenville, NC (Hybrid)

Duration: Contract

Job Description:

The ideal candidates must meet the following qualifications:

• Over 10-15 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 modelling and defining sources of truth.
• Proven experience with MES/Control systems integration (e.g., Delta V, 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, Pharma Suite, PMX, Client-X).
• Proficient in reviewing and troubleshooting recipes, making necessary updates to meet client specifications.
• Familiarity with validation tools such as Kneat and Client 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 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.

With Regards

Shravan

shravan@spiceorb.com