CQV Engineer

Job Title: CQV Engineer

Location: Bangalore

Experience: 3-4 years in pharma CQV

1. Commissioning Activities:

• Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc.
• Participate and coordination with engineering & OEMS for FAT/SAT.
• Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM.

2. Qualification and Validation:

• Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment.
• Perform Qualification as per the regulatory requirements (e.g., FDA, WHO).

3. Documentation:

• Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle.
• Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution.
• Provide technical input during project planning and scheduling of CQV activities.
• Track and report progress of CQV milestones, and support.
• Good knowledge in project management and excellent communication as well as writing skills