CQV Engineer & Validation Specialist – Onsite Puerto Rico

QRC Group; Manatí (PR); Sur place; USD 75 000 - 120 000; Plein temps

Résumé du poste

QRC Group is seeking multiple CQV professionals to support ongoing projects in pharmaceutical, biotechnology, medical device, and other GMP-regulated environments. Positions cover commissioning, qualification, validation, and related documentation, with on-site work in Manatí, Puerto Rico.

You will join a multidisciplinary team and collaborate across Engineering, Operations, Quality, Validation, Automation, IT, Utilities, Maintenance, and Laboratory teams to ensure GMP compliance and timely

Qualifications

• Experience in pharmaceutical, biotechnology, medical device, or GMP-regulated industries.
• Knowledge of GMP, GDP, and applicable regulatory requirements.
• Experience supporting commissioning, qualification, validation activities.
• Strong writing, documentation, and organizational skills.
• Effective communication and cross-functional collaboration.
• Ability to work independently within a multidisciplinary project team.
• On-site work in Manatí, Puerto Rico.

Responsabilités

• Support planning, development, execution, review, and completion of CQV 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, escalate, and support the resolution of risks, deviations, change controls, and technical issues.

Connaissances

GMP knowledge

GDP knowledge

Regulatory compliance

Technical writing

Communication skills

Independent work

Formation

Bachelor’s degree in Engineering, Science, or related technical discipline

Description du poste

QRC Group is seeking multiple CQV professionals to support ongoing projects in pharmaceutical, biotechnology, medical device, and other GMP-regulated environments. Positions cover commissioning, qualification, validation, and related documentation, with on-site work in Manatí, Puerto Rico.

You will join a multidisciplinary team and collaborate across Engineering, Operations, Quality, Validation, Automation, IT, Utilities, Maintenance, and Laboratory teams to ensure GMP compliance and timely