Position Summary
Seeking an experienced Facilities Validation Engineer to support the validation and qualification of critical utility systems within a regulated manufacturing environment. The engineer will support systems serving manufacturing areas and ISO Class 7, 8, and 9 cleanrooms.
The primary assignment will focus on the Humacao facility. The selected candidate will independently develop, review, and execute validation protocols while ensuring compliance with applicable quality requirements, project documentation standards, and established deadlines.
Key Responsibilities
- Develop, review, and execute validation and qualification protocols for compressed air systems, dryers, and air handling units (AHUs).
- Implement established validation strategies and use existing qualification documentation as a reference for project activities.
- Prepare and execute qualification documentation and testing activities, including Installation Qualification (IQ) and Performance Qualification (PQ), as applicable.
- Coordinate validation activities according to the project schedule and planned facility shutdown window.
- Document test results, deviations, and supporting evidence in accordance with applicable procedures.
- Collaborate with Facilities, Engineering, and Quality teams to ensure project requirements are met.
- Travel to other facilities, including Ponce and Villalba, when required.
Qualifications
- Bachelor's degree in Engineering, preferably Mechanical, Electrical, Chemical, or a related engineering discipline.
- Previous experience validating critical utility systems in pharmaceutical, medical device, or other regulated manufacturing environments.
- Hands-on experience developing and executing validation protocols for compressed air systems, dryers, and AHUs.
- Practical knowledge of qualification documentation, including IQ and PQ.
- Ability to work independently and meet strict project deadlines.
- Availability to work on-site during testing, qualification execution, and other critical project activities.
- Strong technical writing, documentation, organizational, and coordination skills.
Additional Requirement: Must be available to support scheduled qualification activities in Humacao, including planned facility shutdown period.
Location: Humacao, Puerto Rico Project Duration: 6 months initially Work Arrangement: Hybrid Compensation: $35–$40 per hour (Depending on Experience) (Professional Services Contract)
Pay: $35.00 - $40.00 per hour
Application Question(s):
- Do you have hands-on experience developing and executing validation protocols for compressed air systems, air dryers, and Air Handling Units (AHUs)?
- Are you available to work on-site in Puerto Rico during qualification testing and scheduled shutdown periods?
- Are you willing to travel between facilities in Ponce, Villalba, and Humacao as needed?
Education:
- Bachelor's (Required)
Work Location: In person
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