Process Engineering and Maintenance Manager

This is a key leadership role for a hands-on, technically skilled professional passionate about process optimization, equipment reliability, and team development within a high-performance, regulated environment.

Key Responsibilities

Process Engineering

• Lead the Process Engineering team to improve existing manufacturing processes, maximize production efficiency, and reduce costs while maintaining quality and compliance.
• Ensure process engineering tasks are executed on time, within budget, and in full compliance with GMP and safety standards.
• Drive continuous improvement and root cause analysis (CAPA) to address yield and quality issues.
• Maintain and update process risk assessments (pFMEA, eFMEA).
• Collaborate cross-functionally with Production, Quality, R&D, Validation, Facilities, and external partners to sustain and improve manufacturing processes.
• Support documentation, process validation, and KPI monitoring to ensure data-driven decision-making and operational excellence.

Maintenance

• Lead and coordinate the Maintenance team to ensure optimal availability and reliability of all equipment and facilities.
• Oversee preventive, predictive, and corrective maintenance programs for ISO 7 cleanrooms, sterilization zones (autoclaves), robotic production lines, HVAC, and controlled ventilation systems.
• Ensure all maintenance activities comply with ISO 13485, GMP, and EHS standards.
• Manage equipment qualification, calibration, and validation activities in collaboration with Quality and Engineering teams.
• Supervise external service providers and ensure full traceability and compliance of maintenance interventions.
• Implement digital tools and reliability-centered maintenance practices to enhance predictive maintenance and data-driven performance.
• Promote energy efficiency and cost optimization initiatives while ensuring equipment reliability and regulatory adherence.