VALIDATION ENGINEER

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’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.

What You Will Do

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 Genesis philosophy applied to industry standard practices to support CQV programs for a variety of different types of projects. This can include (not limited to):

• Preparing CQV plans and CQV checklist documents
• Review contractor submittals and shop drawings
• Developing test strategies and plans with customers and contractors
• Developing CQV schedules
• Performing field inspections of equipment and various MEP/FP systems
• Walk-down design and vendor drawings in the field
• Coordinating with construction managers, contractors, and vendors
• Identifying discrepancies and updating issues logs.
• Witnessing equipment startups
• Attending factory acceptance tests and witness site acceptance testing.
• Perform functional performance testing to ensure systems are working properly.
• Working with the project team to resolve issues
• Participate in the vendor training process
• Preparing final CQV reports and turnover packages
• Develop qualification and validation project plans
• Develop and execute IQ/OQ/PQ protocols
• Write qualification summary reports
• Manage time effectively to efficiently perform work within assigned project budgets and timelines.
• Perform work to meet Genesis and client quality standards
• Perform all work safely, complying with Genesis and client safety standards
  
  

Minimum Qualifications

• Bachelor's or Associate's degree in Engineering or related discipline or an equivalent technical degree and experience
• 2-5 years of experience in a Validation role.
• 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.
• Extensive overnight travel out of state will be required.
  
  

Preferred Qualifications

• Experience with Pharmaceutical, Biotech, Life Science, Healthcare, Laboratory, or Mission Critical industries
• Prior commissioning experience
• Technical writing
• Relevant experience in the field of construction, startup, and/or design
• An understanding of basic cGMP requirements and good documentation practices.
• Experience with some or all of the following:
• Filling Lines
• Isolators
• Packaging Systems
• Autoclaves / Ovens / Parts Washers
• Temperature Mapping
• Lyophilizers
• Computer System Validation
• Various types of clean utilities such as process gases, WFI, and clean steam.
• HVAC Systems
• Building Automation Systems (BAS)
• Monitoring and automation systems such as EMS and PLC systems
• Cleanrooms and laboratories.
  

WHY YOU’LL LOVE IT HERE

• Our collaborative and positive culture sets us apart
• We offer flexible work schedules.
• 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!