Bachelor's degree in Engineering, Life Sciences, or related technical field
3-7+ years of CQV/Validation experience in pharmaceutical or biotechnology sectors
Expertise in IQ/OQ/PQ, FAT/SAT, URS, DQ processes
Strong understanding of GMP and regulatory standards
Knowledge of GAMP 5, FDA regulations, and data integrity principles
Experience handling deviations, CAPA, and change control
Exceptional technical writing and documentation abilities
Capable of independent work as well as teamwork across various disciplines.
Responsibilities
Develop and execute C&Q documentation and activities
Prepare and execute URS, DQ, IQ, OQ, and PQ protocols
Support qualification of equipment, facilities, utilities, and processes
Review engineering documentation and specifications
Execute FAT/SAT activities with vendors and teams
Perform verification, commissioning, and qualification testing in the field
Document test results and manage discrepancies
Support risk assessments and qualification strategy development
Collaborate with cross-functional teams including Engineering and Quality departments
Handle deviation investigations, CAPA, and change control processes
Ensure compliance with GMP and regulatory requirements during qualification activities
Benefits
Comprehensive healthcare coverage
Retirement savings plan with employer matching
Paid time off and holiday leave
Opportunities for professional development and training
Support for work-life balance
Full 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.
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.
bility to work independently and collaborate with cross-functional teams.
