CQV Engineer: GMP Qualification & Commissioning Specialist

Katalyst-Healthcares-; City of Albany (NY); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

A CQV Engineer in Albany, NY is responsible for supporting commissioning and qualification activities for pharmaceutical manufacturing facilities, equipment, utilities, and systems. The role ensures systems are properly commissioned, qualified, documented, and compliant with GMP, FDA, GAMP 5, and applicable regulatory requirements.

The position requires 3–7+ years of CQV/Validation experience and strong knowledge of IQ/OQ/PQ, FAT/SAT, URS, DQ.

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3–7+ years CQV/Validation experience in pharma/biotech or regulated manufacturing.
• Experience with IQ/OQ/PQ, FAT/SAT, URS, DQ.
• Strong GMP and regulatory knowledge.

Aufgaben

• Developing and executing Commissioning and Qualification (C&Q) documentation and activities.
• Preparing and executing URS, DQ, IQ, OQ, and PQ protocols.
• Supporting equipment, facility, utility, and process qualification.
• Reviewing engineering/design documentation, specifications, and P&IDs.
• Developing and executing FAT/SAT activities with vendors and project teams.
• Performing field verification, commissioning, and qualification testing.
• Documenting test results, discrepancies, deviations, and corrective actions.
• Supporting risk assessments and qualification strategy development.
• Collaborating with Engineering, Quality, Manufacturing, Automation, and Validation teams.
• Supporting deviation investigations, CAPA, and change control activities.
• Ensuring qualification activities comply with GMP, FDA, GAMP 5, and company procedures.
• Coordinating with vendors during equipment installation, startup, and qualification.
• Preparing final qualification reports and supporting system release.

Kenntnisse

CQV/Validation

GMP knowledge

Regulatory knowledge

Technical writing

Cross-functional collaboration

Independent work

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Tools

IQ/OQ/PQ

FAT/SAT

URS/DQ

GAMP 5

21 CFR Part 11

Jobbeschreibung

Job Summary:
The CQV Engineer is responsible for supporting commissioning and qualification activities for pharmaceutical or biotechnology manufacturing facilities, equipment, utilities, and systems. The role ensures systems are properly commissioned, qualified, documented, and compliant with GMP, FDA, GAMP 5, and applicable regulatory requirements.

Key Responsibilities:

• Develop and execute Commissioning and Qualification (C&Q) documentation and activities.
• Prepare and execute URS, DQ, IQ, OQ, and PQ protocols.
• Support equipment, facility, utility, and process qualification.
• Review engineering/design documentation, specifications, and P&IDs.
• Develop and execute FAT/SAT activities with vendors and project teams.
• Perform field verification, commissioning, and qualification testing.
• Document test results, discrepancies, deviations, and corrective actions.
• Support risk assessments and qualification strategy development.
• Work with Engineering, Quality, Manufacturing, Automation, and Validation teams.
• Support deviation investigations, CAPA, and change control activities.
• Ensure qualification activities comply with GMP, FDA, GAMP 5, and company procedures.
• Coordinate with vendors and contractors during equipment installation, startup, and qualification.
• Prepare final qualification reports and support system release.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• Typically 3–7+ years of CQV/Validation experience in pharmaceutical, biotechnology, or regulated manufacturing.
• Experience with IQ/OQ/PQ, FAT/SAT, URS, DQ.
• Strong GMP and regulatory knowledge.
• Experience with manufacturing equipment, utilities, facilities, or process systems.
• Knowledge of GAMP 5, FDA, 21 CFR Part 11 and data integrity principles.
• Experience with deviations, CAPA, change control, and risk assessments.
• Strong technical writing and documentation skills.
• Ability to work independently and collaborate with cross-functional teams.