Equipment / Process Engineer (Clean Areas & Process Equipment Enhancements)

Job Description

Job Description

Equipment / Process Engineer (Clean Areas & Process Equipment Enhancements)

Location: Puerto Rico (Open to U.S. Citizens residing in Puerto Rico)

Employment Type: Contract – 100% Onsite

Positions Available: 3

Summary

We are seeking Equipment/Process Engineers to support multiple process equipment and clean area enhancement projects at our client’s manufacturing site in Puerto Rico. The selected professionals will provide engineering and validation support for the qualification, commissioning, and optimization of process and support equipment across various controlled environments.

These positions are part of the client’s initiative to transition operations under Normal Operations and enhance manufacturing reliability, isolator performance, and system sustainability while ensuring compliance with FDA, GMP, and internal quality standards.

Key Responsibilities

• Support and execute qualification and validation activities for process equipment and utility systems initiatives, ensuring compliance with established procedures.
• Provide engineering and validation support for equipment installation, commissioning, and operational readiness within clean and controlled manufacturing environments.
• Contribute to refrigeration system replacements, UV light and isolator upgrades, and process equipment enhancements across multiple areas.
• Participate in root cause analysis (RCA), FMEA, and risk assessments to evaluate equipment performance, identify process improvements, and implement corrective actions.
• Support the replacement, qualification, and validation of critical systems such as gas detectors, spectrophotometers, centrifuges, homogenizers, integrity testers, and tube sealers.
• Collaborate with project managers and cross-functional teams to ensure all engineering deliverables align with project scope, timelines, and regulatory expectations.
• Ensure all technical documentation, validation reports, and change control records meet GMP, FDA, and internal documentation requirements.
• Participate in system design reviews, deviation investigations, and continuous improvement initiatives to enhance aseptic control and system reliability.
• Provide technical guidance to ensure all new and upgraded systems transition smoothly to Normal Operations under program goals.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Electrical, or related discipline).
• 6–8 years of experience in equipment qualification, process validation, or facility engineering within FDA-regulated or aseptic manufacturing environments.
• Strong knowledge of GMP, aseptic processing, isolator systems, and cleanroom design standards.
• Proficiency in commissioning, qualification (IQ/OQ/PQ), and change control management.
• Experience with risk-based validation methodologies (FMEA, RCM, RCA) and reliability-focused equipment qualification.
• Demonstrated ability to manage multiple projects, coordinate with technical teams, and deliver within defined timelines.
• Excellent communication, documentation, and teamwork skills.

Additional Project Scope Includes:

• Process Equipment Qualification and Requalification across multiple areas, Cooler System replacements, and Isolator/UV Light upgrades.
• Process Equipment upgrades, including replacement and validation of homogenizers, centrifuges, spectrophotometers, tube sealers, integrity testers, and gas detector panels.

This position is offered through ProQuality Network as a contract assignment supporting our client’s manufacturing operations in Puerto Rico.