CQV Specialist

Katalyst Healthcares & Life Sciences

1 day ago

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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.

CQV Specialist · Katalyst Healthcares & Life Sciences