CQV Engineer
Novozen Healthcare LLC, Oklahoma City, OK, United States
Job Title: CQV Engineer (Commissioning, Qualification & Validation)
Overview
Our pharmaceutical client is seeking experienced CQV Engineers to support commissioning, qualification, and validation activities for manufacturing systems and process equipment. This role is critical in ensuring systems meet GMP/GDP requirements and comply with regulatory standards.
Key Responsibilities
Execute commissioning and qualification (C&Q) activities for process equipment such as bioreactors, filtration systems, chromatography skids, and ultrafiltration units
Perform drawing walkdowns, equipment/component verification, and materials of construction (MOC) and weld verification
Support operational verification (OV) and protocol execution activities
Develop and/or support SIP (Steam-In-Place) and CIP (Clean-In-Place) cycle development and qualification
Conduct temperature mapping using qualified instruments (Ellab experience preferred)
Utilize validation systems such as eVal (required) and ValGenesis (preferred)
Ensure all validation activities are executed in compliance with GMP/GDP standards and internal procedures
Qualifications
5–10 years of experience in CQV / Validation within the pharmaceutical or biotech industry
Strong hands‑on expertise in process equipment validation
Solid understanding of GMP/GDP principles and regulatory compliance
Experience with temperature mapping and validation software (eVal required)
Excellent communication and teamwork skills
Flexibility to support off‑hours work, including evenings and weekends if needed
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Overview
Our pharmaceutical client is seeking experienced CQV Engineers to support commissioning, qualification, and validation activities for manufacturing systems and process equipment. This role is critical in ensuring systems meet GMP/GDP requirements and comply with regulatory standards.
Key Responsibilities
Execute commissioning and qualification (C&Q) activities for process equipment such as bioreactors, filtration systems, chromatography skids, and ultrafiltration units
Perform drawing walkdowns, equipment/component verification, and materials of construction (MOC) and weld verification
Support operational verification (OV) and protocol execution activities
Develop and/or support SIP (Steam-In-Place) and CIP (Clean-In-Place) cycle development and qualification
Conduct temperature mapping using qualified instruments (Ellab experience preferred)
Utilize validation systems such as eVal (required) and ValGenesis (preferred)
Ensure all validation activities are executed in compliance with GMP/GDP standards and internal procedures
Qualifications
5–10 years of experience in CQV / Validation within the pharmaceutical or biotech industry
Strong hands‑on expertise in process equipment validation
Solid understanding of GMP/GDP principles and regulatory compliance
Experience with temperature mapping and validation software (eVal required)
Excellent communication and teamwork skills
Flexibility to support off‑hours work, including evenings and weekends if needed
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