Project Manager – MES Specialist

JC Automation Corp • Manatí, PR

5d

About The Position

We are looking for a highly technical and experienced Project Manager with deep expertise in Manufacturing Execution Systems (MES) to lead a major Syncade platform upgrade initiative in a sterile pharmaceutical manufacturing environment. This role goes beyond traditional project management — you will serve as both the technical subject matter expert and the project execution leader.
You will drive the upgrade of the Syncade hardware and software platform, manage the migration and validation of Electronic Batch Records across sterile and non-sterile areas, lead technical meetings with stakeholders and the Syncade software developer, and oversee the full C&Q implementation. This is a complex, high-visibility engagement that requires the ability to manage competing priorities across IT, Manufacturing, Quality, Supply Chain, and Engineering teams simultaneously.

Requirements

• Bachelor's degree in Engineering (Computer, Electrical, Chemical, or related discipline), Information Technology, or a closely related technical field.
• Minimum 5 years of experience managing MES implementation or upgrade projects in pharmaceutical or biotech GMP environments.
• Direct hands-on experience with Syncade MES — including eBR development, configuration, and system administration.
• Demonstrated experience managing software migrations and validations in regulated pharmaceutical environments.
• Strong knowledge of cGMP, 21 CFR Part 11, and Data Integrity requirements for electronic systems.
• Experience coordinating C&Q activities and managing C&Q vendors for MES or automation system projects.
• Bilingual in English and Spanish (oral and written).

Nice To Haves

• PMP certification or equivalent project management credential.
• Experience with Syncade Enterprise upgrade projects specifically.
• Familiarity with supply chain integration and impact management during MES upgrades.
• Experience presenting and managing formal Change Control processes to cross-functional review boards.
• GAMP 5 knowledge and experience applying it to MES validation lifecycle.

Responsibilities

• MES Platform Upgrade: Lead the upgrade of the Syncade hardware and software platform to the Enterprise Manufacturing Execution System, ensuring technical integrity and compliance throughout.
• eBR Migration & Validation: Manage the migration, validation, and implementation of all sterile and non-sterile area electronic batch records (eBRs), including new product recipes.
• Technical Leadership: Lead technical meetings with internal stakeholders and the Syncade software developer, providing subject matter expertise and driving alignment on design and implementation decisions.
• Integration Coordination: Coordinate integration windows with impacted manufacturing areas and supply chain, minimizing operational disruptions during the upgrade and migration phases.
• C&Q RFP Development: Develop Commissioning & Qualification RFPs and manage vendor selection in support of the Syncade upgrade implementation.
• Software Integration & Migration Management: Oversee the software integration and data migration process, ensuring traceability, data integrity, and compliance with regulatory expectations.
• C&Q Implementation Management: Manage the end-to-end Commissioning and Qualification (C&Q) implementation, including protocol execution, deviation resolution, and system acceptance.
• Change Control & Financial Management: Manage RFI, submittal, and change order logs; oversee the formal change control process; develop and update project cash flow and integrated project schedule.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior