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Katalyst HealthCares & Life Sciences
MES SpecialistKatalyst HealthCares & Life Sciences • Packanack Lake, NJ
MES Specialist

MES Specialist

Katalyst HealthCares & Life Sciences • Packanack Lake, NJ
30+ days ago
Job type
  • Full-time
Job description

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.
Responsibilities:
Technical Process Expertise
  • Act as the primary SME (Subject Matter Expert) 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.
Implementation Support
  • 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.
Compliance & Documentation
  • Ensure full compliance with FDA, cGMP, and CFR Part regulations.
  • Develop and maintain SOPs, work instructions, and training materials.
  • Support audits and regulatory inquiries with clear, documented responses.
Training & Knowledge Transfer
  • 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.
Continuous Improvement
  • 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.
Required Qualifications:
  • Bachelor's degree in engineering, IT, or Life Sciences (or equivalent experience).
  • + 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 of mindset.

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MES Specialist • Packanack Lake, NJ

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