VALIDATION ENGINEER – Laboratory Equipment Specialist

Genesis AEC•Whitpain Township, PA

About The Position

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’re 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. Our culture is based on inclusion, one where all identities, backgrounds, and perspectives are embraced. When you’re on our team, you’ll find you are supported, challenged, and encouraged to grow – with opportunities, training, and a work-life balance to help you succeed. As a Validation Engineer, you will be part of our Commissioning, Qualification, and Validation (CQV) team that focuses on assuring that projects are installed and operated to meet design and owner requirements. You will utilize the 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):

Requirements

B.S. or A.S. degree in a science or engineering field, a related discipline, or an equivalent technical degree
3-5 years of relevant professional experience.
Experienced with the qualification of various types of laboratory equipment, including refrigerators/freezers/incubators, centrifuges, shakers, bead baths, Milli-Q’s, mixers, shakers, isolators, ovens, ventilated enclosures, etc.
Strong computer skills, proficient with MS Office applications
Strong verbal and written communication skills.
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

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
Proficient in the use of developing and executing qualification protocols using Kneat validation software.
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:
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

Performing design reviews and design qualifications
Developing validation specifications (URS, FRS)
Developing risk assessments, traceability matrices, and system-level impact assessments
Performing field inspections of equipment and various types of clean utility systems
Walk-down design and vendor drawings in the field
Witnessing or participating in vendor FAT and SAT execution
Review of vendor and contractor documentation
Read and understand technical documents to develop test plans
Support the commissioning documentation development and execution as required.
Develop IQ/OQ/PQ protocols for various types of equipment and utilities.
Work with temperature mapping equipment (program, setup, data analysis)
Identifying discrepancies and updating issues logs
Write deviation reports when required
Develop qualification summary reports
Develop Standard Operating Procedures (SOPs)
Organizing and executing work within project budgets and schedules

Benefits

Our collaborative and positive culture sets us apart
We offer flexible schedules
Comprehensive medical, dental, vision, and RX insurance plans, with two-thirds of your premiums and deductible paid!
Competitive 401(k) match program
Generous paid time off (PTO)
Paid Parental Leave
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!