CQV Engineer & Validation Specialist (GMP) – On-site PR

QRC Group; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

CQV Consultants – Engineering & Validation Professionals in Manati, Puerto Rico is seeking multiple CQV professionals to support cross-functional projects across facility, laboratory, utility, automation, and computerized systems. The roles require diverse CQV backgrounds and strong documentation practices.

Ideal candidates will have GMP experience, technical writing skills, and the ability to work independently within a multidisciplinary team on-site in Puerto Rico.

Qualifications

• Experience in GMP-regulated environments (pharma/biotech/medical devices)
• Strong technical writing, documentation and organizational skills
• Excellent communication and cross-functional collaboration abilities
• Ability to work independently within a multidisciplinary project team
• Experience supporting CQV activities and related documentation

Responsibilities

• Plan, develop, execute, review, and complete commissioning, qualification, and validation activities.
• Prepare, review, execute, or oversee qualification protocols, assessments, traceability, and final reports.
• Coordinate project activities and document review with Engineering, Operations, Quality, Validation, Automation, IT, Utilities, Maintenance, and Laboratory teams.
• Ensure deliverables comply with approved procedures, GDP, GMP, and applicable regulatory standards.
• Track activities, deliverables, approvals, and project documentation through completion.
• Identify, document, escalate, and support resolution of risks, deviations, change controls, and technical issues.

Skills

Technical writing

Cross-functional collaboration

Independent work

Communication

Education

Bachelor's degree in Engineering, Science, Computer Science or related technical discipline

Job description

CQV Consultants – Engineering & Validation Professionals in Manati, Puerto Rico is seeking multiple CQV professionals to support cross-functional projects across facility, laboratory, utility, automation, and computerized systems. The roles require diverse CQV backgrounds and strong documentation practices.

Ideal candidates will have GMP experience, technical writing skills, and the ability to work independently within a multidisciplinary team on-site in Puerto Rico.