Job Description

Hi,

Hope you are doing well. This is Dheeraj from Stellent IT .

We are hiring for the given job requirement. If you are interested in this role then please share below details:

1. Updated Resume
2. Current Location
3. Work Authorization
4. LinkedIn Id

Job Title: MES Sr. Consultant

Location: Raleigh, NC (Hybrid_ Onsite but will have remote options 1-2 times a week)

Note: Need same background experience

You will be responsible for:

• Support the development, modeling, configuration, and deployment of electronic Batch Records (eBR) within the MES environment.
• Collaborate with cross-functional teams to gather user requirements, estimate development effort, and deliver accurate, efficient, and "right first time" eBR designs.
• Participate in MES-related activities such as design reviews, system testing, release planning, and solution demonstrations.
• Act as a Subject Matter Expert (SME) for MES capabilities and enhancements related to site-specific or global initiatives.
• Coordinate MES integrations and updates with other enterprise systems such as ERP (e.g., SAP), eLIMS, and other supply chain platforms.
• Plan and execute MES system validation activities in alignment with the Software Development Lifecycle (SDLC), including preparation and execution of CTPs, IOQs, and other qualification protocols.
• Define, implement, and maintain MES standards, templates, and documentation in accordance with global procedures and regulatory compliance.
• Review, revise, and author technical documents, including Standard Operating Procedures (SOPs), Work Instructions (WIs), Technical and Design Specifications, and Qualification Protocols.

Requirements:

• Hands-on experience with eBR design, modeling, and deployment within a Manufacturing Execution System (MES), preferably Syncade.
• Strong understanding of manufacturing and batch record workflows in GMP-regulated environments.
• Familiarity with system validation practices under SDLC frameworks, including authoring and executing CTPs, IOQs, and related test documentation.
• Proven ability to collect and translate business requirements into functional MES solutions.
• Knowledge of integration points between MES and other enterprise systems (e.g., ERP, eLIMS).
• Excellent documentation skills and experience maintaining compliance with regulatory and corporate documentation standards.
• Effective communication and collaboration skills for working with cross-functional and global teams.
• Experience with authoring or revising SOPs, WIs, and technical documentation to support MES processes.
• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field; additional certifications in MES systems or validation are a plus.

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