Senior cGMP Mechanical Engineer

The Mechanical Engineer should have experience in pharmaceutical/biopharmaceutical industry, as well as experience in cGMP environment, including front end process design and process/utility equipment configurations, commissioning, qualification, and validation. Experience developing construction specifications and designs for cleanroom and laboratory HVAC/mechanical systems (including Basis of Design and Schematics). Basic knowledge of system and building controls. Prepare or modify drawings/BIM models in conjunction with CAD/REVIT team at all stages of design. Well-developed communication skills, both verbal and written. Should have demonstrated experience collaborating cross-functionally with internal staff, review of design drawing for approval, understanding of the infrastructure required for the construction of a Cell & Gene Therapy facility, overseeing engineering and construction activities, and preparing turnover documentation and as-built drawings. Monitor and coordinate interdisciplinary work for compliance to applicable mechanical codes, accepted engineering practices and AGI standards. Apply IBC, NFPA, ASTM, and SMACNA requirements to mechanical designs. Construction Administration including RFI and Submittal responses as well as troubleshooting, consulting, and site visits

Based on level, demonstrated project controls skills such as estimating, scheduling and cost reporting. Leadership skills. Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.), as well as Pipe Flo and CFD modeling software. Lead and manage all aspects of assigned complex projects that support improvements to the facility operations.

Requirements:

• Bachelor's Degree with experience in a Pharmaceutical Industry and related regulatory, engineering, and construction techniques.
• Licensed Professional Engineer, or EIT with goal of Professional Engineering license preferred.
• 7-12 years of industry experience.
• Experience working in cGMP biotech environment and with GDP Practices.
• Cell & Gene Therapy experience is preferred, but not a requirement.