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 design of 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 semiconductor wafer 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?
Skills Required
- Bachelor's degree in Life Sciences or Engineering
- Eight years of exposure to Project Services in Pharmaceutical industry
- Bilingual in Spanish and English
- Experience as Cleanroom SME in pharmaceutical or biotech facilities
- Strong knowledge of cleanroom technologies
- Experience supporting CQV activities
What We Do
We are a Service Provider company 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 our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
