CQV Specialist

JobDiva, Inc.; Minneapolis (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

JobDiva, Inc. is seeking an experienced CQV Specialist to support commissioning, qualification, and validation activities within a GMP biomanufacturing environment.

The role involves authoring and executing IQ/OQ/PQ protocols, managing deviations, supporting investigations, and driving qualification activities across upstream and fill-finish systems, including CIP/SIP and process utilities.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
• 10+ years of CQV, Validation, Quality, or Engineering experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience authoring and executing IQ/OQ/PQ protocols.
• Experience writing and managing deviations within a GMP-regulated environment.
• Working knowledge of FDA, cGMP, and validation requirements.
• Strong technical writing and documentation skills, with the ability to communicate clearly and effectively.

Responsibilities

• Author, review, and execute IQ/OQ/PQ protocols and validation reports.
• Develop, revise, and execute qualification documentation in accordance with GMP requirements.
• Support commissioning, startup, and qualification activities for manufacturing equipment and systems.
• Write, investigate, and resolve deviations related to CQV activities.
• Support root cause investigations and CAPA implementation.
• Ensure documentation complies with GMP, GDP, and site quality standards.
• Upstream vessels and bioreactors; Fill-finish lines; Transfer panels and process transfer systems.
• CIP/SIP systems and process utilities; Collaborate with Engineering, Manufacturing, Quality, and Validation teams.
• Support risk assessments, change controls, and project documentation.
• Assist with regulatory inspection and audit readiness activities.

Skills

CQV Expertise

IQ/OQ/PQ Protocols

Regulatory Documentation

GMP Knowledge

Technical Writing

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Role Overview:

• We are seeking an experienced CQV Specialist to support commissioning, qualification, and validation activities within a GMP biomanufacturing environment. This individual will play a key role in ensuring manufacturing equipment and systems are qualified, documented, and compliant with regulatory requirements. The CQV Specialist will author and execute validation protocols, manage deviations, support investigations, and drive qualification activities across upstream and fill-finish manufacturing systems.

Roles and Responsibilities:

• Author, review, and execute IQ/OQ/PQ protocols and validation reports.
• Develop, revise, and execute qualification documentation in accordance with GMP requirements.
• Support commissioning, startup, and qualification activities for manufacturing equipment and systems.
• Write, investigate, and resolve deviations related to CQV activities.
• Support root cause investigations and CAPA implementation.
• Ensure documentation complies with GMP, GDP, and site quality standards.
• Upstream vessels and bioreactors
• Fill-finish manufacturing lines
• Transfer panels and process transfer systems
• CIP/SIP systems and process utilities
• Collaborate with Engineering, Manufacturing, Quality, and Validation teams.
• Support risk assessments, change controls, and project documentation.
• Assist with regulatory inspection and audit readiness activities.

Education and Experience:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
• 10+ years of CQV, Validation, Quality, or Engineering experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience authoring and executing IQ/OQ/PQ protocols.
• Experience writing and managing deviations within a GMP-regulated environment.
• Working knowledge of FDA, cGMP, and validation requirements.
• Strong technical writing and documentation skills, with the ability to communicate clearly and effectively.