CQV Consultants – Engineering & Validation Professionals
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Skills
change controlcommissioninggmpgood documentation practicestechnical writing
About the role
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, escalate, 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 Manatí, Puerto Rico, as required by the project.