Validation Engineer I
WHO WE ARE
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. WHAT YOU WILL DO 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 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.
Minimum Qualifications - 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
- Hybrid working arrangements are permitted with management approval; however, client and project demands may require up to 5 days a week onsite
- Able to commute to multiple job sites during the workweek
- Resourceful and self-motivated
- Overnight travel will be required when supporting out-of-town projects (most projects are within 50 miles of the Genesis office)
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.
Preferred Qualifications - 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.
Additional Information for California Applicants: Salary Range: $60,000.00 - $70,000.00. The base salary range represents the low and high ends of the anticipated salary range for this position in the Orange County, CA market. The actual base salary offered for this position will be 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.
WHY YOU'LL LOVE IT HERE - Our collaborative and positive culture sets us apart
- We offer schedule flexibility. For field-based personnel, flexible scheduling may be subject to client/project site requirements.
- 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
- And so much more!
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.
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