MES Lead

JC Automation Corp•Las Piedras, PR

4d•Onsite

About The Position

We are seeking a technically strong and operationally experienced MES Field Services Lead to serve as the primary on-site IT point of contact for Manufacturing Execution System (MES) operations and all Technology Services activities at a pharmaceutical manufacturing site. This role combines deep hands-on MES technical expertise with broad IT coordination responsibilities in a 24/7 GxP-regulated environment. The ideal candidate brings proven experience supporting MES platforms in life sciences, strong knowledge of IT infrastructure, and the leadership skills to manage L2 teams and coordinate cross-functional technical activities.

Requirements

Proven experience supporting MES platforms (PAS-X or equivalent) in a GxP-validated pharmaceutical or life sciences manufacturing environment.
Familiarity with MES integrations: APIs, OPC, middleware, and interfaces with ERP, LIMS, or SCADA systems.
Windows Server administration, patching management, and infrastructure troubleshooting experience.
Working knowledge of LAN/WAN/WLAN networking and IT infrastructure support in a regulated manufacturing setting.
Strong understanding of 21 CFR Part 11, data integrity, change control, and validation lifecycle (IQ/OQ/PQ).
Proven experience managing P1/P2 critical incidents and coordinating cross-functional resolution in fast-paced environments.
Demonstrated ability to lead L2 teams, manage service queues, and hold vendors accountable to SLAs.

Nice To Haves

Familiarity with ISA-95/ISA-88 manufacturing standards.
Exposure to PLC/SCADA systems or data reporting and historian tools.
Experience with EBR (Electronic Batch Record) systems and electronic logbooks.
Bachelor's degree in Computer Science, Information Technology, Engineering, or a related technical field.

Responsibilities

Configure, maintain, and support the Manufacturing Execution System (PAS-X), including workflows, user accounts, SOPs, equipment labels, printers, scales, and system interfaces.
Manage MES and server patching, performance monitoring, troubleshooting, and vendor liaison activities.
Own change control, validation activities, audit trails, access reviews, and periodic system reviews in full compliance with GxP requirements and 21 CFR Part 11.
Ensure all system activities are documented and traceable in accordance with data integrity standards.
Act as the on-site SPOC for all Technical Systems services, including P1/P2 critical incident management, enterprise project coordination, infrastructure deployments, and end-user escalations.
Support manufacturing workstations, manage EHS contractor coordination, and oversee general business ticket management.
Maintain working knowledge of LAN/WAN/WLAN networking and infrastructure troubleshooting to ensure operational continuity.
Lead and develop L2 support personnel, monitor IRIS service queues, set work priorities, and ensure third-party vendors meet established SLAs.
Foster a proactive, service-oriented team culture aligned with site operational needs.
Develop and maintain SOPs, work instructions, and technical documentation, submitting to Document Control as required.
Provide training to site personnel and act as site liaison for EBR Designer and L1 support teams.
Provide on-call support as required to meet the demands of a continuous 24/7 manufacturing environment.
Ensure rapid response to critical system incidents that could impact production operations.