GMP Process Architect - Cleanroom

For Senior Cleanroom / GMP Process Architect - Life Sciences & Advanced Manufacturing Services 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Architecture, Engineering, or related discipline and eight (8) years ofexperience in cleanroom, GMP, or high-tech manufacturing facility design. 
• Extensive experience in pharmaceutical, biotech, gene therapy, or advanced manufacturing facilities.
• Shift: Administrative and according to business needs.
• Experience in:

  • Strong knowledge of:

    • ISO 14644 cleanroom standards

    • cGMP facility design principles

    • HVAC zoning and pressurization strategies

    • Contamination control and material/personnel flow

  • Experience working on large-scale, capital projects  expansions, and renovations.

  • Proven ability to lead multidisciplinary teams and interface with clients and regulators.

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL:(The day-to-day on the job)

• Lead conceptual, preliminary, and detailed designof cleanrooms and controlled environments (ISO 3–8) for sterile and non-sterile manufacturing.

• Develop cleanroom zoning strategies, airflow models, pressure cascades, and HVAC concepts to meet contamination control requirements.

• Define personnel and material flows, gowning concepts, airlocks, and segregation strategies.

• Specify cleanroom finishes, filtration systems, cleaning strategies,and utilities distribution aligned with process requirements.

• Coordinate cleanroom layouts with process equipment, tool installations, skids, and utility interfaces.

• Support semiconductorwafer fabrication, biotechnology, cell & gene therapy, and high-containment processing environments.

•  Ensure facility designs support scalability, flexibility, and future expansion.
• Ensure alignment with cGMP, ISO 14644, FDA, EMA, ISPE, PDA, and GLP requirements.
• Participate in GMP reviews, risk assessments, and regulatory readiness activities.
• Support development of Basis of Design (BOD), User Requirements (URS), and technical documentation.
• Serve as technical lead or subject matter expert (SME) for cleanroom and process architecture.
• Collaborate with MEP engineers, validation teams, construction managers, and vendors.
• Support design-build and IPD delivery models, including construction administration and field coordination.

WHO WE ARE:

We are a service provider company that is different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on the well-being of our resources while providing our pharmaceutical, medical device, and manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

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