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 of experience 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?
