Senior Equipment Maintenance Engineer
Job Summary
The Senior Equipment Maintenance Engineer ensures the reliable operation, maintenance, and lifecycle management of sterile manufacturing process equipment. This role provides technical leadership for maintenance activities, reliability improvements, and capital projects. The position ensures full compliance with GMP, regulatory, safety, and quality standards within a sterile manufacturing environment.
Responsibilities
- Manage maintenance lifecycle for sterile manufacturing equipment
- Lead troubleshooting and root cause investigations
- Execute preventive/predictive maintenance plans
- Oversee equipment qualification and compliance (GMP)
- Manage capital projects and equipment commissioning
Required Skills
- 7+ years in pharmaceutical/biotech maintenance
- Expertise in sterile/fill-finish equipment
- Strong knowledge of GMP and regulatory standards
- CMMS proficiency (e.g., IBM Maximo)
- Troubleshooting and analytical problem-solving
Job Details
RESPONSIBILITIES:
Equipment Reliability & Maintenance:
- Own the maintenance strategy and lifecycle management for assigned sterile manufacturing process equipment and clean utility systems.
- Lead troubleshooting, repair, and root cause investigations to improve equipment reliability and reduce unplanned downtime.
- Plan, schedule, and execute preventive and predictive maintenance activities in alignment with production requirements.
- Monitor equipment performance and implement reliability improvements to maximize equipment availability and operational efficiency.
- Support calibration and maintenance activities to ensure equipment remains in a validated state.
Technical Ownership:
- Serve as the Subject Matter Expert (SME) for assigned process equipment throughout its lifecycle.
- Provide technical support to Manufacturing, Quality, Validation, Automation, and Engineering teams.
- Develop and maintain equipment maintenance strategies, SOPs, preventive maintenance plans, and technical documentation.
- Evaluate equipment performance trends and recommend engineering improvements to enhance reliability, maintainability, and productivity.
Equipment & Systems:
- Support the maintenance and reliability of equipment including IMA internal and external vial washers, Sterilization tunnels, Vial filling and capping machines, Tray loading systems, Isolators, Formulation equipment, Autoclaves, Parts washers, HVAC systems, Secondary packaging equipment, Laboratory equipment, and Clean utility systems.
Compliance & Quality:
- Ensure maintenance activities are performed in accordance with GMP, EHS, Data Integrity, and site quality requirements.
- Support equipment qualification, requalification, and validation activities.
- Lead or support change controls, deviations, investigations, CAPAs, and risk assessments.
- Maintain accurate and complete maintenance documentation within the CMMS.
Asset Management:
- Develop and maintain equipment spare parts strategies and inventory optimization.
- Track maintenance KPIs and drive continuous improvement initiatives to improve OEE.
Projects:
- Lead and support capital projects involving equipment installation, upgrades, modifications, commissioning, startup, and qualification.
- Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and equipment commissioning activities.
REQUIREMENTS:
- Bachelor's degree in Mechanical, Electrical, Mechatronics, or related Engineering discipline.
- Minimum 7 years of maintenance engineering experience within pharmaceutical, biotechnology, or regulated environments.
- Demonstrated experience supporting sterile manufacturing, aseptic processing, or fill-finish operations.
- Hands-on experience maintaining vial filling, formulation, sterilization, and clean utility equipment.
- Knowledge of GMP, FDA, EMA, PIC/S, and applicable regulatory requirements.
- Proficiency in CMMS (preferably IBM Maximo).