Equipment Maintenance/Process Engineer

Job Summary

We are seeking an experienced Engineer to support a critical compliance and operational excellence initiative within a regulated medical device manufacturing environment. The successful candidate will lead the development, implementation, and optimization of preventive maintenance (PM) and calibration programs, ensuring alignment with FDA regulations, quality system requirements, and industry best practices. This role will work closely with Engineering, Maintenance, Quality Assurance, Validation, and Manufacturing teams to establish robust maintenance and calibration procedures, improve CMMS utilization, and ensure the site is inspection-ready.

Note: This is an initial 3-6 months contract.

Essential Duties and Responsibilities

• Develop, review, and implement Preventive Maintenance (PM) procedures for manufacturing equipment, utilities, and automated systems.
• Create and standardize calibration procedures for critical process and utility instrumentation.
• Ensure maintenance and calibration activities comply with FDA, GMP, ISO 13485, and internal quality system requirements.
• Assess and optimize the interaction between maintenance processes and the site's Computerized Maintenance Management System (CMMS).
• Configure and improve CMMS workflows, asset hierarchies, maintenance plans, scheduling, and documentation controls.
• Establish maintenance and calibration strategies based on equipment criticality and risk assessments.
• Review existing maintenance documentation and identify compliance gaps.
• Support audit readiness activities by ensuring maintenance and calibration records are complete, accurate, and inspection-ready.
• Collaborate with Validation and Quality teams to ensure procedures meet regulatory and data integrity requirements.
• Train maintenance and engineering personnel on newly developed procedures and CMMS processes.
• Support investigations, CAPAs, and change control activities related to equipment maintenance and calibration.
• Provide recommendations for continuous improvement of maintenance reliability and compliance programs.

Work Experience

• 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.
• Strong understanding of FDA regulations, GMP requirements, and inspection readiness expectations.
• Hands-on experience with CMMS platforms such as SAP PM, or equivalent systems.
• Experience authoring controlled procedures, work instructions, and maintenance documentation.
• Knowledge of equipment lifecycle management, calibration management, and asset reliability principles.
• Strong technical writing and documentation skills.
• Excellent stakeholder management and cross-functional communication abilities

Preferred Knowledge, Skills and Abilities

• Experience supporting FDA inspections or regulatory audits.
• Familiarity with ISO 13485, 21 CFR Part 820, and current FDA Quality Management System requirements.
• Knowledge of validation principles, including CSV and equipment qualification.
• Experience within automated assembly or medical device manufacturing environments.
• Certification in Reliability Engineering, Maintenance Management, or related disciplines is advantageous.