CQV 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 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.

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 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 CQV 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 commissioning program for a variety of different types of projects. This can include (not limited to):

• Developing commissioning specifications
• Preparing commissioning plans and commissioning checklist documents
• Review contractor submittals and shop drawings
• Developing test strategies and plans with customers and contractors
• 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
• Communicating status regularly to the client and internal management
• identifying discrepancies and updating issues log.
• Witnessing equipment startups
• Attending factory acceptance tests
• Working with the testing and balancing contractor to ensure systems are properly balanced
• Perform functional performance testing to ensure systems are working properly
• Review the testing and balancing process and reports
• Working with the project team to resolve issues
• Participate in the vendor training process
• Preparing final commissioning reports and turnover packages
• Develop qualification and validation project plans
• Develop and execute IQ/OQ/PQ protocols
• Develop qualification summary reports
• Organizing and executing work within project budgets and schedules.

• BA or AS degree in engineering or related discipline, or an equivalent technical degree and experience
• Demonstrated strengths in Facility, Utilities, HVAC, BAS, and/or Electrical Systems
• Understanding of cGMP basic principles and Good Documentation Practices commonly used in the pharmaceutical industry.
• Experienced in writing and executing IQ/OQ protocols, writing summary report,s and writing lifecycle documentation.
• 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.
• Overnight travel will be required when supporting out-of-town projects

• 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:
  • Facility and utility systems: HVAC (source equipment, distribution), central plants (chilled water, hot water, steam), electrical distribution systems and equipment, air compressors, plumbing systems, and fire protection systems.
  • Building Automation Systems (BAS)
  • Monitoring and automation systems, such as EMS and PLC systems
  • Various types of clean utilities, including process gases, WFI, and clean steam.
  • Clean rooms and laboratories.
  • Process Equipment
  • Laboratory Equipment

• Our collaborative and positive culture sets us apart
• We offer schedule flexibility, including 9-hour days Monday-Thursday and 4-hour Fridays, all year long; daily hours that work with your commuting or personal obligations;
  Hybrid schedule - 3 days/week in an office.
• Comprehensive medical, dental, vision, and Rx insurance plans, withtwo-thirds of your premiums and deductible paid!
• Competitive 401(k) match program
• Generous paid time off
• Thought leadership opportunities, including a $1,000 awardfor presenting or publishing your technical expertise!
• Competitive company-paid training opportunities
• A 5% salary increase for earning your professional license!
• Flexible opportunities to grow your career