Technical Director

Clear.; Conshohocken (Montgomery County); On-site; USD 180,000 - 220,000; Full time

Benefits offered by this job

Bonus

Full benefits

Job summary

Clear. is seeking a Technical Director / SME for cGMP life sciences (mechanical) in Conshohocken, PA, with open locations in Dallas, Raleigh-Durham, and Phoenix. Base salary starts at $200,000 DOE with full benefits and bonus.

This role keeps you hands-on with engineering, defining design basis and philosophies for a defensible concept. You will own mechanical concepts for cGMP manufacturing and cleanroom facilities, manage HVAC and utilities, and produce the essential calculations and designs

Qualifications

• Must have mechanical engineering degree with PE license.
• Deep experience with cGMP facilities, cleanrooms and high-purity utilities.
• Familiarity with ISPE and GAMP expectations and regulatory scrutiny.

Responsibilities

• Own the mechanical concept and design basis for cGMP manufacturing and cleanroom facilities.
• Lead cleanroom HVAC, containment strategy, and clean utilities design.
• Produce calculations, system selections and design philosophies for detailed design.
• Advise clients at feasibility and concept stage with options studies and basis-of-design docs.
• Ensure documentation meets FDA/EMA scrutiny and set technical standards for the mechanical group.

Skills

cGMP knowledge

Cleanroom HVAC

Design basis & calculations

FDA/EMA regulatory familiarity

Education

Mechanical Engineering degree

Professional Engineer (PE) license

Job description

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