CQV Engineer

Genesis AEC•Medford, MA

13h•Hybrid

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 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. 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): Performing design reviews 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 Developing commissioning 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 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 lifecycle documentation (URS, VMP, Risk Assessments, Trace Matrices, etc.) 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.

Requirements

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

Nice To Haves

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.
Cleanrooms and laboratories.
Process Equipment
Laboratory Equipment

Responsibilities

Performing design reviews
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
Developing commissioning 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
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 lifecycle documentation (URS, VMP, Risk Assessments, Trace Matrices, etc.)
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.

Benefits

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, with two-thirds of your premiums and deductible paid!
Competitive 401(k) match program
Generous paid time off
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!
Flexible opportunities to grow your career