CQV Consultants – Engineering & Validation Professionals

QRC Group

Manatí (PR)

Sur place

USD 90 000 - 120 000

Plein temps

Il y a 11 jours

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Résumé du poste

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

Responsabilités

  • 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.

Connaissances

Technical writing
Cross-functional collaboration
Independent work
Communication

Formation

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

Description du poste

CQV Consultants – Engineering & Validation Professionals

Manati, Puerto Rico | Posted on 10/16/2026

QRC Group is seeking multiple Commissioning, Qualification & Validation (CQV) professionals to support several ongoing projects. These opportunities support facility, laboratory, utility, automation, and computerized system improvement initiatives, requiring professionals with diverse CQV backgrounds and levels of experience.We are building a multidisciplinary team and are looking for qualified candidates across several technical areas.

Common Primary Responsibilities
  • Support the planning, development, execution, review, and completion of commissioning, qualification, and validation activities.
  • Prepare, review, execute, or oversee qualification and validation protocols, assessments, traceability documentation, and final reports.
  • Coordinate project activities and document review cycles with Engineering, Operations, Quality, Validation, Automation, IT, Utilities, Maintenance, and Laboratory teams, as applicable.
  • Ensure that project deliverables comply with approved procedures, good documentation practices, GMP requirements, and applicable regulatory standards.
  • Track assigned activities, deliverables, approvals, and project documentation through completion.
  • Identify, document, escalates, and support the resolution of risks, deviations, change controls, and technical issues.
Requirements
  • Experience working in pharmaceutical, biotechnology, medical device, or another GMP-regulated industry.
  • Knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
  • Experience supporting commissioning, qualification, validation, or validation documentation activities.
  • Strong technical writing, documentation, and organizational skills.
  • Effective communication and cross-functional collaboration skills.
  • Ability to work independently and as part of a multidisciplinary project team.
  • Ability to manage assigned deliverables and maintain accurate, compliant, and timely documentation.
  • Bachelor's degree in Engineering, Science, Computer Science, or a related technical discipline, depending on the position.
  • Ability to work on-site in Manati, Puerto Rico, as required by the project.
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