Commissioning & Qualification Lead – Puerto Rico

Grupoeosol; Manatí (PR); On-site; USD 120,000 - 180,000; 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 plan, coordinate, and execute C&Q activities for process equipment, utilities, facilities and related systems, ensuring safety, schedule, and GMP compliance in collaboration with the project team.

The role involves leading cross-functional teams, supporting FATs/SATs, audits, and turnover, and applying

Qualifications

• Experience leading commissioning & qualification activities on large projects.
• Strong knowledge of process equipment, utilities, and facilities in pharma.
• Familiarity with FATs, SATs, and system turnover processes.

Responsibilities

• Lead and coordinate C&Q activities across assigned systems and project areas.
• Plan schedules, resources, and deliverables with the C&Q Manager.
• Review documentation for completeness, traceability, and GMP compliance.
• Support deviations, non-conformances, test failures, and punch lists.

Skills

C&Q leadership

GMP compliance

project coordination

risk-based approach

Education

Bachelor's degree in engineering or life sciences

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.