Job Title: CQV Engineer

Location: Los Angeles, CA (Onsite)

Overview:

Seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical/biotechnology manufacturing environment. The role involves hands-on execution of validation protocols, equipment qualification, and ensuring compliance with regulatory standards.

Required Experience:

• 3+ years of CQV experience in Pharma/Biotech GMP environment
• Hands-on experience with Commissioning, Qualification (IQ/OQ/PQ), and Validation activities
• Experience with equipment qualification (upstream/downstream/process equipment, utilities, HVAC, cleanrooms)
• Strong knowledge of cGMP, FDA regulations, and data integrity requirements
• Protocol authoring and execution (URS, FAT, SAT, IQ, OQ, PQ)
• Experience with process validation and cleaning validation
• Deviation management, CAPA, and change control experience
• Familiarity with Kneat, Veeva, or other validation documentation systems

Key Responsibilities:

• Author, review, and execute commissioning and qualification protocols (IQ/OQ/PQ).
• Support equipment, utility, and facility validation activities.
• Ensure compliance with FDA, cGMP, and regulatory requirements.
• Coordinate with engineering, manufacturing, and QA teams for validation deliverables.
• Manage deviations, change controls, and CAPA related to validation activities.
• Maintain accurate documentation in validation management systems.