MES Specialist

Job Description

The candidate will serve as the technical process expert for manufacturing systems such as MES, SCADA, LIMS, and Track & Trace. This role involves ensuring system compliance, driving process improvement, and supporting cross‑functional teams during implementations and audits.

• Act as the primary SME for systems such as MES, SCADA, LIMS, and Track & Trace Systems (ACG, Systech, e‑Logbooks).
• Understand complete workflows, integration points, and regulatory implications.
• Provide direction during upgrades, configuration changes, and process improvements.
• Collaborate with IT, Engineering, Operations, and Quality to deploy new systems or enhancements.
• Troubleshoot complex system/process issues and provide advanced technical insights.
• Participate in vendor discussions to ensure technical alignment and site compatibility.
• Ensure full compliance with FDA, cGMP, and 21 CFR Part 11 regulations.
• Develop and maintain SOPs, work instructions, and training materials.
• Support audits and regulatory inquiries with clear, documented responses.
• Conduct end‑user training and knowledge‑sharing sessions.
• Mentor junior members and promote cross‑functional learning.
• Maintain a knowledge base for troubleshooting and best practices.
• Analyze performance data to recommend efficiency and compliance improvements.
• Lead root cause analysis and CAPA (Corrective and Preventive Actions) for recurring issues.
• Stay updated on industry trends and emerging technologies.

• Bachelor's degree in engineering, IT, or Life Sciences (or equivalent experience).
• 5+ years of experience in manufacturing or automation within a regulated environment.
• Proven expertise in at least one system MES, LIMS, Track & Trace, or SCADA.
• Strong understanding of cGMP, FDA, and other global regulatory frameworks.
• Excellent communication, analytical, and problem‑solving skills.
• Experience with system integrations (ERP, MES, WMS, LIMS, SCADA, Track & Trace).
• Strong leadership and collaboration skills across multi‑site environments.
• High attention to detail and a continuous improvement mindset.

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Other

Industries: Business Consulting and Services