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.

Requirements

• 10+ years of experience in commissioning, qualification, validation, and/or engineering.
• Extensive field experience leading or coordinating CQV activities on large-scale Life Sciences capital projects.
• Bachelor's degree or higher in Engineering, Science, Life Sciences, or a related discipline.
• Experience in biotechnology, pharmaceutical, or medical device industries strongly preferred.
• Experience with one or more of the following:
• Facilities
• Clean Utilities
• Process Utilities
• HVAC
• Process Equipment
• Water Systems
• Manufacturing Systems
• Laboratory Systems
• Strong knowledge of GMP requirements and risk-based C&Q principles.
• Familiarity with FDA expectations, ICH Q8/Q9/Q10, ISPE guidance, Annex 1, ISO standards, and relevant industry standards.
• Experience supporting deviations, change controls, non-conformances, and corrective actions.
• Strong experience developing, reviewing, and executing C&Q documentation and protocols.
• Experience working with equipment vendors, engineering contractors, site operations, and construction teams.
• Strong organizational, communication, leadership, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced capital project environment.

Preferred Experience

Preference will be given to candidates with experience in:

• Cleanrooms
• HVAC
• Process gases
• Purified Water
• WFI
• Clean Steam
• Biologics manufacturing
• Sterile manufacturing environments
• Aseptic Fill-Finish
• Bulk Drug Substance manufacturing
• Process Automation and Computerized Systems
• Building Management Systems (BMS)
• Manufacturing Execution Systems (MES)
• Laboratory and manufacturing automation
• FAT/SAT
• System Turnover
• Operational Readiness