Senior CQV Engineer: GMP Validation Leader

Katalyst CRO; Montpelier (VT); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking an experienced Senior CQV Engineer to lead Commissioning, Qualification, and Validation activities for life sciences manufacturing facilities in the United States. The role focuses on equipment, utilities, facilities, and systems, ensuring compliance with GMP, FDA, GxP, and ISPE standards.

The incumbent will develop CQV plans, write and review URS, DQ, IQ, OQ, PQ documents, and manage risk assessments, CAPAs, and deviations.

Competenze

• Bachelor's degree in mechanical, electrical, chemical, biomedical, pharmaceutical, or related Engineering discipline.
• Typically 7-10+ years of CQV/validation experience in pharmaceutical, biotech, medical device, or other regulated industries.
• Strong knowledge of GMP/GxP validation requirements.
• Excellent technical writing, communication, leadership, and problem-solving skills.

Mansioni

• Lead CQV activities for manufacturing equipment, utilities, facilities, and systems.
• Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols.
• Develop CQV plans, validation strategies, protocols, reports, and traceability documentation.
• Review engineering specifications, P&IDs, drawings, equipment documentation, and vendor packages.
• Coordinate and execute FAT/SAT activities with vendors, Engineering, Quality, and project teams.
• Perform equipment and utility qualification activities in accordance with approved procedures.
• Develop and execute risk assessments, including FMEA and criticality assessments.
• Ensure validation activities are aligned with GMP/GxP, FDA, EU GMP, GAMP 5, and ISPE requirements.
• Support commissioning activities and transition systems from construction through qualification and operational readiness.
• Manage deviations, discrepancies, change controls, and CAPA associated with CQV activities.
• Perform root cause analysis and implement corrective and preventive actions.
• Review and approve test results, qualification packages, and validation reports.

Conoscenze

Technical leadership

Technical writing

Communication

Problem solving

Formazione

Bachelor's degree in mechanical, electrical, chemical, biomedical, pharmaceutical engineering

Descrizione del lavoro

Katalyst CRO is seeking an experienced Senior CQV Engineer to lead Commissioning, Qualification, and Validation activities for life sciences manufacturing facilities in the United States. The role focuses on equipment, utilities, facilities, and systems, ensuring compliance with GMP, FDA, GxP, and ISPE standards.

The incumbent will develop CQV plans, write and review URS, DQ, IQ, OQ, PQ documents, and manage risk assessments, CAPAs, and deviations.