We are seeking a Compliance Validation Engineer to lead the development and optimization of preventive maintenance (PM) and calibration programs. In this role, you will drive a critical compliance initiative within a regulated medical device environment, ensuring full alignment with FDA regulations and GMP standards.
The Role:
- Lead the development, review, implementation, and optimization of Preventive Maintenance (PM) and calibration procedures for manufacturing equipment, utilities, automated systems, and critical instrumentation.
- Ensure maintenance and calibration activities comply with FDA, GMP, ISO 13485, and internal quality system requirements while supporting audit readiness.
- Configure, assess, and improve Computerized Maintenance Management System (CMMS) workflows, asset hierarchies, maintenance plans, scheduling, and documentation controls.
- Establish maintenance and calibration strategies based on equipment criticality, risk assessments, and equipment lifecycle management principles.
- Collaborate cross-functionally with Validation, Engineering, and Quality teams to author controlled procedures and support investigations, CAPAs, and change controls.
- Train maintenance and engineering personnel on newly developed procedures and CMMS processes.
Requirements:
- Associate's or Bachelor's Degree in Engineering, Automation, Mechatronics, Manufacturing Engineering, or a related technical discipline.
- Minimum 5 years of experience in a regulated manufacturing environment (medical devices, pharmaceuticals, biotechnology, or similar).
- Demonstrated experience developing PM and calibration programs from the ground up, supported by strong technical writing and hands-on CMMS platform experience (e.g., SAP PM).
- Strong understanding of FDA regulations, GMP requirements, and inspection readiness expectations.
