About the Job

Our Team/Overview:

Senior Maintenance Engineer is under the remit of Reliability & Maintenance function, which is part of the Site Engineering & Maintenance organization.

Main Accountabilities:

• Timely execution of preventive/corrective maintenance

• HSE considerations for maintenance (permits, PTW, LOTO)

• WO accuracy and completeness

• Continuous improvement for maintenance operations

Key involvement in Decision Making process

Key roles (D,A,I):

• I: maintenance plans, procedures, work instructions

• A: shop organization and safety (incl. tools, equipment)

• A: maintainability improvements (accessibility, safety, CI)

• A: feedback to reliability engineering and P&S team

Local specificities

Additional Accountabilities:

• Develop a maintenance plan in alignment with Failure Modes and Effects Analysis (FMEA) by incorporating risk management strategies and proactive maintenance practices to prevent equipment failures.

• Ability to create preventive and predictive maintenance strategies for manufacturing equipment, ensuring that the maintenance plan aligns with the global maintenance strategy approach.

• Knowledge in setting up an initial inventory of spare parts based on the criticality of equipment and manufacturer recommendations, ensuring smooth plant operations after startup.

• Ensure that all equipment maintenance activities and setups comply with applicable industry regulations such as cGMP, FDA guidelines, and other relevant standards.

• Proficiency in using SAP to track maintenance schedules, manage work orders, maintain spare parts inventories, and record maintenance history.

• Familiarity with the specialized equipment used in biopharmaceutical plants, including bioreactors, filtration systems, chromatography systems, autoclaves, and clean-in-place (CIP) systems.

• Oversee the maintenance, repair, and troubleshooting of key equipment utilized in the manufacturing process.

• Address equipment failures or breakdowns promptly to minimize production downtime and maintain smooth operations.

• Maintain thorough documentation for compliance purposes, including the creation of maintenance plans, work order logs, change requests, deviations, and corrective actions.

• Collaborate closely with production, quality control, and engineering teams to identify equipment issues, suggest solutions, and implement necessary changes.

• Coordinate with vendors and suppliers for maintenance services and spare parts procurement.

• Identify opportunities to optimize processes, reduce costs, and enhance efficiency in relation to equipment and maintenance practices.

• Assist in training maintenance technicians on proper equipment operation, maintenance procedures, and safety protocols.

• Ensure all maintenance activities are performed safely, adhering to company safety policies, risk assessments, and regulatory requirements.

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