Genesis AEC · 21 hours ago
Validation Engineer I (Temporary 3+ Months)
Irvine, CA
Full-time
Onsite
Entry Level
$29/hr - $33/hr
1+ years expGenesis AEC is an award-winning architecture, engineering, construction management, and CQV firm in the life sciences industry. As a Validation Engineer I, you will support the CQV team in ensuring that projects meet design and owner requirements, focusing on documentation, field inspections, and project planning.
ConstructionArchitecture & DesignArchitectureCivil Engineering
Responsibilities
Write and perform CQV documentation [Commissioning / IQ/OQ/PQ protocols for various types of equipment, facility systems, and utilities]
Performing field inspections of equipment and various types of utility systems
Walk-down design and vendor drawings in the field
Witnessing or participating with the vendor performing FAT, SAT, and Functional Testing
Review of vendor and contractor submittals, startup reports, and documentation
Read and understand technical documents
Performing design reviews and design qualifications
Developing validation specifications (URS, FRS)
Developing risk assessments, traceability matrices, and system-level impact assessments
Developing CQV project plans and Validation plans
Perform temperature mapping, including (program, setup, and data analysis)
Identifying discrepancies and updating issue logs
Develop Standard Operating Procedures (SOPs)
Organizing and executing work within project budgets and schedules
Qualification
Required
Bachelor's degree in Science or Engineering
Minimum 1 - 2 years of previous experience, internship experience can be included
Strong computer skills, proficient with MS Office applications
Strong oral and written communication skills
Resourceful and self-motivated
Ability to put on cleanroom gowning and work in cleanroom / cGMP spaces, lift 25 pounds, stand for sustained durations during testing, and wear PPE (safety shoes, hard hat, safety glasses, etc.)
Ability to work in construction, packaging, manufacturing, and laboratory spaces
Preferred
Experience with Pharmaceutical, Biotech, Life Science, and Laboratory industries
Technical writing
Proficient in the use of temperature mapping equipment such as Vaisala, Kaye AVS, or Sensitech dataloggers
Demonstrated understanding of reviewing/writing technical documents, risk assessment reports, commissioning/validation documents, IOQ/PQ protocols, and final reports
An understanding of basic cGMP requirements and good documentation practices
Experience with some of the following: Laboratory equipment such as temperature control units (refrigerators, incubators, freezers), biosafety cabinets, centrifuges, pumps, tube sealers, tube welders, autoclaves, parts washers, and ovens
Monitoring and automation systems, such as EMS and PLC systems
Various types of process equipment, such as mixing tanks, bioreactors, filling line equipment, packaging equipment, fluid bed dryers, spray dryers, and isolators
Various types of clean utilities, such as process gases, WFI, and clean steam
Cleanrooms and HVAC systems
Benefits
This temporary position is not eligible for benefits, except those required under California law.
Company
Genesis AEC
Since its inception, Genesis AEC – an award-winning architecture, engineering, and construction firm – has helped life sciences companies usher in the next generation of life-saving therapies, treatments, and technologies.
201-500 employees
H1B Sponsorship
Genesis AEC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (126)
2024 (68)
2023 (20)
2022 (2)
2021 (13)
2020 (29)
Funding
Current Stage
Growth StageLeadership Team
Meryl A. Towarnicki, AIA, LEED AP
EVP Chief Technology Officer
Company data provided by crunchbase