CQV Lead - Pharma Commissioning & Qualification

FITS LLC; Barceloneta (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

FITS is seeking a CQV professional to support Global Engineering in a fast-paced regulated environment in Barceloneta, Puerto Rico. The role focuses on coordinating commissioning and qualification activities for process and utility systems, ensuring GMP compliance, and leading documentation development and audits.

The candidate will collaborate with engineers, vendors, and site operations while maintaining project milestones and risk-based approaches to CQV execution.

Qualifications

• Bachelor’s degree in Life Science or Engineering with 7+ years in commissioning, qualification, validation in regulated industry.
• Bilingual in Spanish and English.
• Strong communication, organizational and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced project environment.
• Experience coordinating or leading C&Q activities on pharmaceutical capital projects.
• Experience with facilities, clean utilities, HVAC, water systems, process equipment, or laboratory systems.
• Developing, reviewing and executing C&Q documentation and protocols.
• Supporting deviations, change controls, non-conformances, and corrective actions.
• Coordinating with engineering contractors, equipment vendors, construction teams, and site operations.

Responsibilities

• Lead and coordinate day-to-day C&Q activities for assigned systems and project areas.
• Coordinate C&Q engineers, subject matter experts, contractors, and equipment vendors.
• Support the C&Q Manager in developing and maintaining C&Q plans, schedules, resource requirements, and deliverables.
• Ensure C&Q activities are incorporated into the integrated project schedule and delivered in line with project milestones.
• Apply risk-based commissioning and qualification principles to assigned systems.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support the investigation and resolution of deviations, non-conformances, test failures, punch-list items, and other C&Q issues.
• Coordinate with engineering, construction, quality, operations, maintenance, automation, project controls, and external vendors.
• Provide regular updates on C&Q progress, risks, issues, and schedule performance.
• Support factory acceptance testing, site acceptance testing, system turnover, operational readiness, and project handover activities.
• Support audits, inspections, and project readiness reviews as required.
• Ensure all activities are performed in accordance with applicable health, safety, environmental, quality, and GMP requirements.

Skills

Bilingual Spanish & English

Strong communication

Problem solving

Multitasking

Education

Bachelor's degree in Life Science or Engineering

Job description

FITS is seeking a CQV professional to support Global Engineering in a fast-paced regulated environment in Barceloneta, Puerto Rico. The role focuses on coordinating commissioning and qualification activities for process and utility systems, ensuring GMP compliance, and leading documentation development and audits.

The candidate will collaborate with engineers, vendors, and site operations while maintaining project milestones and risk-based approaches to CQV execution.