Description

Execute commissioning, qualification, and validation (CQV) activities onsite for cGMP equipment and systems. Manage the full lifecycle of validation documentation using KNEAT.

Responsibilities

• Perform IQ/OQ execution for cGMP equipment and systems.
• Author, route, execute, and approve validation documentation using KNEAT.
• Conduct equipment and system testing, documenting results electronically in real time.
• Develop test scripts, acceptance criteria, and traceability documentation.
• Manage deviations and support resolution through digital workflows.

Required Skills

• 5+ years proven hands-on CQV execution experience in GMP manufacturing environments.
• Strong working knowledge of the KNEAT digital validation platform.
• Experience with IQ/OQ execution (PQ experience is a plus).
• Ability to manage documentation-intensive validation projects.
• Bachelor's degree.

Key Skills

Education

Bachelor's degree