GMP Process Architect Cleanroom
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Job Location:
Wilson, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
For Senior Cleanroom / GMP Process Architect - Life Sciences & Advanced ManufacturingServices
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree inArchitecture Engineering or related disciplineand eight(8) years ofexperience in cleanroom GMP or high-tech manufacturing facility design.
- Extensive experience in pharmaceutical biotech gene therapy or advanced manufacturingfacilities.
- 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 other words being a customer service pro is one of your (many) talents. Being the Piece means youre 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 38) 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 strategiesand utilitiesdistributionaligned 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 companythat is different from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
Key Skills
- APIs
- Pegasystems
- Spring
- SOAP
- .NET
- Hybris
- Solution Architecture
- Service-Oriented Architecture
- Adobe Experience Manager
- J2EE
- Java
- Oracle
