Validation Engineer I (Temporary 3+ Months)
About The Position
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 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.
Requirements
- Bachelor's degree in Science or Engineering
- Minimum 1 - 3 years of previous experience, internship experiences can be included if in a GMP environment.
- Strong computer skills, proficient with MS Office applications
- Strong oral and written communication skills
- Resourceful and self-motivated
- Physical requirements include: 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.
- Please note that this facility produces antibiotics; you must sign off on the client safety requirements.
Nice To Haves
- 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.
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
- 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.
Benefits
- This temporary position is not eligible for benefits, except those required under California law.
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What This Job Offers
Career Level
Entry Level
