Onsite Maintenance & Compliance Engineer (GMP/FDA)

ProQuality Network; Northern (KY); Hybrid; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network seeks a Maintenance Engineering Support Specialist to provide hands-on technical and compliance support to a multidisciplinary maintenance team. The role ensures utility and process systems stay in line with corporate policies, standards, and FDA requirements, working across English and Spanish communications.

Key duties include supporting regulatory inspections, audits, and investigations, plus developing SOPs and training.

Qualifications

• Detail-oriented and highly organized.
• Fluent in English and Spanish for documentation and communication.
• Strong understanding of GMP, FDA and ISO in regulated environments.

Responsibilities

• Provide engineering and compliance support for utility systems and process maintenance.
• Ensure maintenance operations meet regulatory and quality standards.
• Act as liaison for engineering issues, inspections, validations, and audit responses.
• Support investigations related to environmental or water system alerts and deviations.
• Assist with development and execution of audits, SOPs, and training.
• Review and propose improvements to maintenance and sanitization procedures.
• Collaborate with plant engineering on system upgrades and compliance enhancements.

Skills

Attention to detail

Bilingual English/Spanish

Regulatory compliance

GMP / FDA / ISO knowledge

Tools

MAXIMO

Job description

ProQuality Network seeks a Maintenance Engineering Support Specialist to provide hands-on technical and compliance support to a multidisciplinary maintenance team. The role ensures utility and process systems stay in line with corporate policies, standards, and FDA requirements, working across English and Spanish communications.

Key duties include supporting regulatory inspections, audits, and investigations, plus developing SOPs and training.