TECHNICAL DIRECTOR / SME - cGMP / LIFE SCIENCES (MECHANICAL)
Conshohocken, PA - Also open to Dallas, Raleigh-Durham and Phoenix
From $200,000 base DOE
Bonus
Full benefits
Our client is a global engineering and construction partner behind some of the largest cGMP manufacturing facilities under construction in the US - biologics, fill-finish, API and advanced therapies.
This is a technical authority role for someone who wants to stay hands-on with the engineering rather than move into delivery management. You define the design basis, set the philosophies, and give the project team a defensible concept to run with.
What you'll be doing
- Owning the mechanical concept and design basis for cGMP manufacturing and cleanroom facilities
- Cleanroom HVAC, pressure cascades and containment strategy; clean utilities including WFI, purified water, clean steam and process gases; black utilities and central plant
- Producing the calculations, system selections and design philosophies the detailed design is built on
- Advising clients at feasibility and concept stage, including options studies and basis-of-design documentation
- Working to ISPE and GAMP expectations, with documentation that stands up to FDA and EMA scrutiny
- Setting technical standards across the mechanical group and reviewing the wider team's work
What we're looking for
- Degree in Mechanical Engineering; PE required
- Strong track record on cGMP or comparable high-purity capital projects - pharma, biotech, medical device, or transferable semiconductor/cleanroom experience
- Real depth in cleanroom HVAC and clean utility systems on the facilities side, rather than product or R&D design
- Familiarity with validated environments and how design decisions carry through to qualification
- Based in or willing to relocate to the one of the locations listed at the top
Technical Director in conshohocken at Unknown Company
This position is listed as full time and onsite.