Senior CQV Lead – Biologics GMP Capital Project

NIRAS; Barceloneta (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

NIRAS is seeking a Commissioning & Qualification Lead for a long-term contract on a large scale Capital Engineering Project in Puerto Rico. The role involves supporting the Commissioning & Qualification Manager in planning and executing C&Q activities for Process Equipment, Utilities, Facilities, and related systems.

The ideal candidate will have 10 years’ experience in CQV, strong leadership skills, and a solid GMP background, with proficiency in English and Spanish.

Qualifications

• 10 years’ experience in commissioning, qualification, validation, engineering.
• Deep field experience leading/coordinating CQV activities on large scale life science projects.
• Familiarity with GMP requirements and risk-based C&Q principles.

Responsibilities

• Lead and coordinate C&Q activities for systems and project areas.
• Develop and maintain C&Q schedules, plans, resources, and deliverables.
• Ensure all C&Q activities meet GMP, FDA, and project requirements.

Skills

CQV Leadership

Project Coordination

GMP Compliance

English/Spanish Proficiency

Education

Engineering degree or higher

Job description

NIRAS is seeking a Commissioning & Qualification Lead for a long-term contract on a large scale Capital Engineering Project in Puerto Rico. The role involves supporting the Commissioning & Qualification Manager in planning and executing C&Q activities for Process Equipment, Utilities, Facilities, and related systems.

The ideal candidate will have 10 years’ experience in CQV, strong leadership skills, and a solid GMP background, with proficiency in English and Spanish.