Unity · 5 hours ago
CQV Engineer/CQV/Validation
Lebanon, IN
Contract
Onsite
Senior Level, Lead/Staff
15+ years expUNITY Systems is seeking a highly experienced Senior CQV Engineer to support commissioning, qualification, and validation activities for a gene therapy manufacturing facility. This role requires deep hands-on expertise in equipment CQV, protocol authoring from scratch, and execution within a regulated GMP environment.
3D TechnologyReal Time
Responsibilities
Lead Commissioning, Qualification, and Validation (CQV) activities for gene therapy manufacturing equipment
Author validation protocols from scratch , including IQ, OQ, and PQ, and execute approved protocols
Perform hands-on qualification of process equipment, utilities, and facility systems
Support validation of single-use systems , aseptic processing equipment, and cleanroom operations
Collaborate with engineering, quality, automation, and manufacturing teams to ensure compliance with GMP requirements
Ensure validation documentation meets regulatory standards and internal procedures
Support computerized system validation (CSV) activities as required
Participate in deviations, change controls, and validation impact assessments
Qualification
Required
15+ years of CQV experience in regulated pharmaceutical or biotech environments
Mandatory experience with gene therapy equipment
Proven experience authoring and executing IQ/OQ/PQ protocols independently
Strong technical writing skills with attention to compliance and detail
Hands-on experience with facility and equipment qualification
Solid understanding of single-use technologies, aseptic processing, utilities, and CSV
Bachelor's degree in Engineering or Life Sciences (or equivalent)
Preferred
Experience supporting startup or expansion of gene therapy or cell therapy facilities
Familiarity with FDA, EMA, and global GMP regulations
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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reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (53)
2024 (55)
2023 (39)
2022 (81)
2021 (62)
2020 (78)
Funding
Current Stage
Late StageLeadership Team
Jim Whitehurst
Chief Executive Officer
John Riccitiello
CEO
Recent News
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