Senior Technical MES Leads in Greenville, NC

Location -Greenville, NC (Candidate Needs to work 3 Days at the Client Office- Tuesday, Wednesday and Thursday

Number of days onsite -Candidate needs to Work in EST Time Zone

Mandatory if Applicable

• Domain Experience (If any ) :-Yes- Pharmaceutical Manufacturing Industry is Mandatory
• Must have Certifications –No

Must Have Skills –

• Skill 1 – 10-15 Yrs of Exp – experience in MES/Automation execution within the Pharmaceutical Manufacturing Industry.
• Skill 2 – 10+ Yrs of Exp – GMP requirements and compliance for complex MES solutions.
• Skill 3 – 10-15 Yrs of Exp – Pharma Manufacturing processes including filling, compounding, formulation, OSD, fractionation, purification, etc.
• Skill 4 – 10+ Yrs of Exp – manufacturing processes into MES solutions across various ISA-95 layers, ensuring proper data modeling and defining sources of truth.
• Skill 5 – 10+Yrs of Exp - MES/Control systems integration (e.g., DeltaV, FactoryTalk, DCS, etc.).
• Skill 6- 10+Yrs of Exp- SAP order management, inventory, and materials management modules, with a focus on MES integration.
• Skill 7 – 10+ Yrs of Exp – design and implementation of MES software (e.g., Syncade, PharmaSuite, PMX, PAS-X).
• Skill 8 – 10+ Yrs of Exp – validation tools such as Kneat and HP ALM.
• Skill 9 – 10+ Yrs of Exp – developing MES validation strategies, test scripts, and execution plans.
• Skill 10 – 10+ Yrs of Exp – delivering MES training across all levels of the organization (e.g., operators, supervisors, quality teams).

We are seeking two highly qualified Senior Technical MES Leads to support and drive a critical, complex MES project based in Greenville, NC.

• The project involves full integration with the Automation Layer and systems across Levels 3 and 4 of the ISA-95 model.
• This project is already in progress, and we require individuals who are local to Greenville or can travel frequently to meet the project's evolving needs. Immediate availability is required.

Due to the urgent need, please, provide potential candidates by end of day Monday, 23 February 2025.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 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.

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