Senior CQV Engineer

Katalyst CRO; Montpelier (VT); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Technical leadership

Technical writing

Communication

Problem solving

Ausbildung

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

Jobbeschreibung

Job Description

We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards.

Job Description

We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards.

Responsibilities

• Lead Commissioning, Qualification & Validation (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 appropriate corrective and preventive actions.
• Review and approve test results, qualification packages, and validation reports.
• Coordinate with Engineering, Automation, Manufacturing, Quality Assurance, Facilities, and external vendors.
• Provide technical leadership and mentoring to junior CQV engineers.
• Support project schedules, resource planning, and CQV deliverables.

Requirements

• 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.