CQV Engineer

Katalyst CRO; City of Albany (NY); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a CQV Engineer to support commissioning and qualification activities for pharmaceutical/biotech 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 candidate will develop and execute CQV documentation, review P&IDs, and coordinate with cross-functional teams to ensure successful system releases and regulatory compliance

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• Typically 37+ 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.

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.

Skills

GMP knowledge

Regulatory knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Tools

URS/DQ/IQ/OQ/PQ workflow

P&IDs review

Job description

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.

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 37+ 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.