Validation Engineer I
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.
Requirements
- Associate's and/or Bachelor's degree in Science or Engineering
- Minimum 0 - 2 years of previous experience, internship experience can be included.
- Strong computer skills, proficient with MS Office applications
- Strong oral and written communication skills
- Able to commute to multiple job sites during the workweek
- Resourceful and self-motivated
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 or all 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: EMS and PLC systems
- Various types of process equipment, like 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 in a 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.
Benefits
- Comprehensive medical, dental, vision, and RX insurance plans, with two-thirds of your premiums and deductible paid!
- Competitive 401k match program
- Generous paid time off
- Thought leadership opportunities, including a $1,000 award for presenting or publishing your technical expertise!
- Competitive company-paid training opportunities
- A 5% salary increase for earning your professional license!
- Endless opportunities to grow your career
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
