Unity · 5 hours ago
CQVEngineer
Los Angeles, CA
Contract
Onsite
Senior Level
$50/hr - $60/hr
5+ years expUNITY Systems is seeking an experienced CQV Engineer to support facilities and utilities qualification activities at a pharmaceutical/biotech construction site in Los Angeles, CA. This hands-on role involves executing commissioning, qualification, and validation for GMP facilities and equipment, along with daily site inspections and collaboration with various teams to ensure compliance.
3D TechnologyReal Time
Responsibilities
Execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for GMP facilities and equipment
Perform Environmental Monitoring Performance Qualification (EMPQ) activities
Support vessel qualification including mixing studies and temperature mapping
Conduct daily construction site job walks in full PPE to support CQV execution and issue resolution
Support qualification and validation of utilities systems , including:
WFI (Water for Injection)
Clean Utilities (Alcohol, Nitrogen, Compressed Air, etc.)
Provide CQV support for:
CIP systems and CIP skids
Cleaning Validation
Filter Presses
Centrifuges
Review and approve CQV documentation including protocols, reports, and turnover packages
Work closely with Engineering, Construction, Quality, and Operations teams to ensure GMP compliance
Identify and resolve field issues, deviations, and punch list items
Qualification
Required
5–10 years of CQV / Commissioning & Qualification experience in pharmaceutical, biotech, or life sciences facilities
Strong experience with Facilities CQV and GMP utilities
Hands-on experience executing IQ/OQ/PQ and EMPQ
Familiarity with construction site CQV execution
Ability to work onsite full-time and perform daily job walks in full PPE
Strong understanding of cGMP, FDA, and regulatory requirements
Excellent documentation, communication, and cross-functional collaboration skills
Preferred
Experience with Cleaning Validation
Experience supporting CIP skids, filter presses, and centrifuges
Experience in large-scale capital projects or greenfield facilities
Background in pharmaceutical manufacturing or biotech facilities
Company
Unity
Unity [NYSE: U] offers a suite of tools to create, market, and grow games and interactive experiences across all major platforms from mobile, PC, and console, to extended reality.
5001-10000 employees
H1B Sponsorship
Unity has a track record of offering H1B sponsorships. Please note that this does not
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Funding
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Late StageLeadership Team
Jim Whitehurst
Chief Executive Officer
John Riccitiello
CEO
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