Title: Equipment/Process Engineer (Clean Areas & Isolator Enhancements)
Location: Puerto Rico (Open to Puerto Rico Residents who are U.S. Citizens)
Employment Type: Contract – 100% Onsite
Positions Available: 3
Summary:
We are seeking Equipment/Process Engineers to support clean area projects and isolator enhancement initiatives at our client’s site in Puerto Rico. The selected professionals will focus on engineering support, process improvements, and system upgrades associated with isolator environments—without direct operation of the isolators. This role ensures that all activities related to cleanroom and isolator system improvements comply with GMP, FDA, and internal quality standards.
Key Responsibilities:
- Lead and support projects related to cleanroom design improvements, isolator system enhancements, and associated infrastructure upgrades.
- Execute engineering activities for equipment installation, commissioning, and qualification in controlled environments.
- Collaborate with cross-functional teams to assess system performance and recommend design or process improvements to enhance aseptic control.
- Ensure all technical documentation and change controls are completed in compliance with corporate procedures, GMP, and FDA regulations.
- Participate in risk assessments, deviation resolutions, and process optimization activities related to isolator and clean area enhancements.
Qualifications:
- Bachelor’s or Master’s degree in Engineering or a related technical field.
- 6–8 years of experience in process equipment engineering, facility modifications, or validation within FDA-regulated aseptic environments.
- Strong understanding of GMP, aseptic processing, isolator technology, and cleanroom design principles.
- Demonstrated ability to manage technical projects and collaborate effectively across engineering, quality, and operations teams.
This position is offered through ProQuality Network as a contract assignment supporting our client’s manufacturing site.
📩 Interested candidates are invited to apply through the job description link and submit an updated resume for consideration.