Commissioning & Qualification Lead - Puerto Rico
Grupoeosol
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 .
Vacancy posted 1 hour ago
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