Commissioning & Qualification Lead – Puerto Rico

Grupoeosol; Barceloneta (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

EOSOL is seeking an experienced Commissioning & Qualification (C&Q) Lead to support a major capital engineering project at a biologics manufacturing facility in Puerto Rico. You will provide day-to-day technical leadership for C&Q activities across process equipment, utilities, and facilities, ensuring compliance with GMP, HSE, and project requirements.

The role may involve coordination with QA, Engineering, and external vendors, leading risk-based commissioning and qualification, and supporting

Qualifications

• Extensive commissioning and qualification leadership for pharma capital projects.
• GMP and regulatory expectations knowledge.
• Experience with biologics facilities and aseptic environments is a plus.

Responsibilities

• Coordinate C&Q schedules, plans, and resources with the C&Q Manager.
• Lead C&Q activities across systems and project areas.
• Coordinate engineers, SMEs, contractors, and vendors.
• Work with Engineering, Quality, Operations, and external partners.
• Prepare, review, and turnover C&Q documentation.
• Support FATs, SATs, and system readiness activities.
• Ensure compliance with HSE, Quality, and GMP requirements.

Job description

Location: Puerto Rico

Industry: Pharmaceutical / Biotechnology / Life Sciences

Project: Large-Scale Capital Engineering Project

Employment Type: Long-Term Contract

Position Overview

EOSOL is looking for an experienced Commissioning & Qualification (C&Q) Lead to support a major capital engineering project at an advanced Biologics manufacturing facility in Puerto Rico.

The C&Q Lead will support the client's C&Q Manager in planning, coordinating, and executing commissioning and qualification activities for Process Equipment, Utilities, Facilities, and related systems.

The position will provide day-to-day technical leadership, ensuring C&Q activities are executed safely, on schedule, and in accordance with project requirements, company procedures, GMP expectations, and applicable industry standards.

The role may also support projects involving Aseptic Fill-Finish, Bulk Drug Substance, and other pharmaceutical manufacturing environments.

Key Responsibilities

• Support the C&Q Manager with C&Q schedules, plans, resources, and deliverables.
• Lead and coordinate C&Q activities across assigned systems and project areas.
• Coordinate C&Q Engineers, SMEs, contractors, and equipment vendors.
• Work closely with Engineering, Construction, Quality, Operations, Maintenance, Automation, Project Controls, and external vendors.
• Ensure C&Q activities are incorporated into the integrated project schedule.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Apply risk-based commissioning and qualification principles.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support the investigation and resolution of deviations, non-conformances, test failures, and punch-list items.
• Provide regular updates regarding C&Q progress, risks, issues, and schedule performance.
• Support FATs, SATs, System Turnover, Operational Readiness, and Project Handover.
• Support audits, inspections, and project readiness reviews.
• Ensure all activities comply with applicable HSE, Quality, and GMP requirements.