Genesis AECValidation Engineer I (Temporary role)
We're Genesis AEC – an award-winning architecture, engineering, construction management, and CQV firm and a leader in the life sciences industry.
Ranked #5 in Pharmaceutical Design by ENR magazine, we are designing and constructing facilities that advance worldwide health. We're proud to contribute to our Client's success, earning honors that include a 2021 ISPE Facility of the Year (FOYA) award and an ENR Mid-Atlantic's Best Manufacturing Project award for our work at the National Institutes of Health.
As a Validation Engineer I, you will be part of our Commissioning, Qualification, and Validation (CQV) team that ensures that projects are installed and operated to meet design and owner requirements.
The selected candidate will be responsible for supporting the creation and execution of documentation required in the commissioning, qualification/validation, and start-up across multiple types of process equipment involving but not limited to packaging equipment, assembly automation, filling, molding, control, and robotic systems.
You will utilize Genesis' philosophy applied to industry standard practices to plan and implement a CQV program for a variety of different types of projects.
This can include (not limited to):
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.
Bachelor's degree in Science or Engineering
Minimum - 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.
Experience with Pharmaceutical, Biotech, Life Science, and Laboratory industries
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.
Compensation, Duration & Location
On-Site with the Genesis team at our Client's location in Orange County, CA
$29 - $ 33/hour
This temporary position is not eligible for benefits, except those required under California law.
Additional Information for California Residents. The pay rate represents the low and the high end of the anticipated pay rate offered for this position in Orange County, CA, and is based on various factors, including but not limited to work location, qualifications, skills required, and relevant work experience.
All your information will be kept confidential.
Are you ready to unlock your potential with us? With your passion and our vision, there's no limit to what you can accomplish here Submit your resume today for immediate consideration.
¿Te interesa este puesto?