CQV Associate

Position: CQV Associate I Role at OmniaBio
Join Omnia Bio as an Associate I, specializing in Commissioning, Qualification, and Validation. Contribute to our mission of transforming biomanufacturing through your expertise in compliance and documentation.

In this role, your responsibilities will include developing validation master plans and ensuring all equipment and processes comply with GMP standards. Working collaboratively with key departments, you will create and manage necessary documentation while also preparing for audits and assessments required for our innovative therapies.

Key Responsibilities:

• Validate development of equipment and system qualifications

• Collaborate to establish documentation requirements

• Keep track of validation schedules and deadlines

• Prepare temperature mapping protocols

• Support completion of change controls and assessments

Requirements:

• At least 1 year in a biopharma GMP setting

• Post-secondary education in engineering technology preferred

• In-depth knowledge of clean room and regulatory standards

• Strong skills in technical writing

• Experience with regulatory guidelines for regenerative medicine

Leverage your skills in a dynamic atmosphere at Omnia Bio, shaping the future of cell and gene therapies.
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