Bachelor's degree in Mechanical, Electrical, Chemical, Facilities Engineering, or a related field.
4 years of experience in facilities engineering within a medical device manufacturing environment.
Experience with cGMP, ISO, and FDA regulations.
Familiarity with robotic technologies and custom automated systems design using SolidWorks.
Understanding of chemical processing methods and process control systems (PID, PLC, PFD, instrumentation).
Responsibilities
Research and test design ideas for feasibility using Lean Manufacturing and Six Sigma methodologies.
Provide engineering support, operation, and maintenance for chemical adhesive manufacturing facilities.
Ensure the reliable performance of HVAC, electrical distribution, and environmental control systems.
Support compliance with OSHA and EPA regulations.
Lead investigations into site manufacturing and facilities systems performance and propose optimizations.
Manage new site projects, including design guidance and liaising with site functions.
Full Job Description
Summary:
Chemence Medical, Inc. seeks Facilities Engineer in Alpharetta, GA.
Key Duties and Responsibilities:
Research and test design ideas to determine feasibility, utilizing Lean Manufacturing, Kaizen, Six Sigma, and/or root cause analysis to formulate/support innovation, corrective actions, and continuous improvement for all machinery.
Responsible for the engineering support, operation, and maintenance of facility and utility systems that support chemical adhesive manufacturing operations in Clean Rooms/QA & QC Areas.
Ensures the reliable and compliant performance of building infrastructure and process support systems, including HVAC, electrical distribution, compressed air, and environmental control systems.
Supports compliance with applicable federal, state, and local regulations, including OSHA and EPA requirements.
Lead engineering investigations into performance of site manufacturing, packaging, facilities and utilities systems, and development of proposals to optimize performance.
Project management for new site projects and for large projects, including design guidance, review and approval, and liaison with site functions, as site engineering representative.
Must have a Bachelor's degree (or its foreign equivalent) in Mechanical, Electrical, Chemical, Facilities Engineering, or a related engineering-driven field.
Must have 4 years of experience in a facilities engineering role working in a medical device manufacturing environment.
Must include experience working within cGMP, ISO and FDA regulations; experience with Robotic technologies; and experience with mechanical and electrical design of custom automated systems with SolidWorks and SolidWorks Electrical software.
Must have familiarity with chemical processing methods such as distillation and scale-up.
Must include understanding of process control systems such as PID, PLC, PFD, instrumentation.
