Sr CQV Engineer (TCU & HVAC)

VTI Life Sciences•Oceanside, CA

6d•Onsite

About The Position

VTI Life Sciences is seeking an experienced Commissioning and Qualification (C&Q) Engineer to support a laboratory and facility expansion project at a regulated biopharmaceutical manufacturing site in Oceanside, California. The C&Q Engineer will work on-site as an integrated member of the project team, supporting the commissioning and qualification of laboratory infrastructure, HVAC systems, clean utilities, non-GMP utilities, and temperature-controlled equipment. This role requires strong technical writing skills, hands-on field execution experience, and familiarity with paperless validation systems. Candidates must be local or willing to relocate.

Requirements

Bachelor’s degree in engineering, life sciences, or a related technical discipline.
At least five years of dedicated commissioning and qualification experience in the pharmaceutical, biotechnology, medical-device, or another regulated industry.
Demonstrated experience authoring, reviewing, and executing C&Q protocols.
Hands-on experience commissioning or qualifying HVAC and utility systems.
Experience with clean utilities such as WFI, clean steam, and compressed air.
Experience commissioning non-GMP utilities.
Experience executing temperature mapping studies and analyzing mapping data.
Strong understanding of Good Manufacturing Practices and controlled-documentation requirements.
Excellent technical writing, organization, problem-solving, and communication skills.
Ability to collaborate effectively with multidisciplinary internal teams, contractors, equipment vendors, and external stakeholders.
Ability to work on-site in Oceanside, California, for the duration of the assignment.

Nice To Haves

Experience supporting laboratory construction, renovation, relocation, or expansion projects.
Experience with temperature-controlled units, including refrigerators, freezers, incubators, stability chambers, or controlled-temperature spaces.
Experience working in a paperless validation environment.
Experience with eVal or a comparable electronic validation platform.
Familiarity with risk-based commissioning and qualification practices.
Experience managing discrepancies and deviations through documented resolution and closure.
Prior experience supporting fast-paced biopharmaceutical capital projects.

Responsibilities

Develop, review, and execute commissioning and qualification plans, protocols, test scripts, and reports.
Perform hands-on commissioning and qualification of facility, laboratory, utility, and temperature-controlled systems.
Support C&Q activities for HVAC systems serving laboratory and controlled environments.
Execute commissioning and qualification activities for clean utilities, including: Water for Injection (WFI), Clean steam, Compressed air, Other GMP-critical utility systems.
Support commissioning activities for non-GMP facility utilities.
Plan and execute temperature mapping studies for temperature-controlled units and spaces.
Analyze temperature mapping results and prepare supporting documentation and final reports.
Record test results, observations, and objective evidence within a paperless validation platform.
Identify, document, investigate, and support the resolution of discrepancies, deviations, and test exceptions.
Coordinate protocol execution with Engineering, Quality, Validation, Facilities, Operations, vendors, and other project stakeholders.
Ensure C&Q documentation complies with approved procedures, project requirements, and applicable regulatory expectations.
Participate in system walkdowns, field verification, turnover-package reviews, and readiness assessments.
Support document review, approval, execution, and closure according to the project schedule.
Communicate project status, technical issues, risks, and recommended resolutions to project leadership.