Validation Engineer

Validation Engineer I

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 byENRmagazine, 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 anENRMid-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 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.

• 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.

• 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 data loggers
• 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.
  • Clean rooms and HVAC systems.