Maintenance Manager

For our client situated in region Ghent and active in biotechnology developing and manufacturing novel therapies, we are looking for a Maintenance Manager.

Role Overview

This position will be part of the Engineering and Maintenance organization within the Technical Operations group and will be responsible for managing the Maintenance team to ensure that all assets are properly maintained and all on-site reactive, preventive and predictive maintenance activities are performed in compliance with production schedules. Furthermore, this role will provide technical assistance to the maintenance engineers to support with diagnosing, troubleshooting, repairing and maintenance for all types of process equipment, instruments and systems for cGMP Clinical and Commercial Cell Therapy Manufacturing in the facilities in Ghent, Belgium. This role will require people management skills, technical expertise and troubleshooting ability and shall drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Major Responsibilities:

Develop, lead and coach a team of Maintenance Engineers to ensure that all critical systems/assets and all maintenance activities in all areas of responsibility comply with all company and/or site Quality & EHS policies and procedures, user requirements, local and federal regulations (e.g., FDA/EU cGMP) and industry standards, guidance and expectations

Cultivate an efficient, professional and safe working environment and ensure objectives are met within intended time frames

Develop and oversee the planning and execution of maintenance and calibration activities for production equipment

Ensure capable and qualified resources are available to perform maintenance for continuous operation of production equipment

Develop troubleshooting guides and equipment spare parts lists as required by the asset and/or system

Ensure that all assets are properly maintained and all on-site reactive, preventive and predictive maintenance activities (e.g., work orders, safety inspection, day-to-day equipment and systems support) are performed in compliance with production schedules

Responsible for ensuring the reliability of the process equipment and supporting the curative maintenance during continuous operation

Ensure documentation of all maintenance activities is properly and timely completed in the computerized maintenance management system (CMMS) following good documentation practices (GDP). Complete all other work associated with the assignment whilst working cooperatively with others

Provide technical assistance to all Maintenance Engineers to support with diagnosing, troubleshooting, repairing and maintenance for all types of process equipment, instruments and systems

Act as subject matter expert (SME) for technical questions and ensure job plans are accurate and able to be safely executed

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Qualification

Education:

Bachelor's Degree in Engineering (Mechanical/Electrical/Bio) or any other related field or equivalent experience required

Experience:

A minimum of five (5) years of experience in maintenance, engineering or operations within an industrial manufacturing or regulated environment with a minimum of three (3) years supervisory experience is required. Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions is preferred.

Capabilities, Knowledge, and skills:

Proven capabilities in developing and leading teams. Must be responsible and able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members

A good understanding of technical installations, process equipment, facilities and computerized systems within an industrial manufacturing or regulated environment

Working knowledge of Building Management Systems, PLCs, HMIs, sensors, and other components

Familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory

Ability to identify/remediate gaps in processes, equipment, facilities and systems

Ability to troubleshoot problems for highly technical equipment

Ability to read and interpret technical English, equipment manuals and complex mechanical, pneumatic and electrical blueprints

Experience in working with validated and qualified process equipment and systems, and associated documentation

Broad knowledge and understanding of cGMP, FDA/EU and Industry regulations, standards, guidance and expectations

Ability to provide support during internal and external regulatory audits

Self-starter, highly organized and capable of working effectively in a team environment with a positive attitude under some supervision

Excellent interpersonal and written/oral communication skills, teamwork oriented

Ability to interact with all levels within the organization and build strong partnerships with Operations, Manufacturing Excellence and Quality

Ability to pay attention to details and follow procedures

Ability to summarize and present results, and experience with team-based collaborations is a requirement

Experience in authoring and executing documentation including, but not limited to: (electronic) Batch Records, SOPs and Work Instructions

Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint)

Experience with SAP, CMMS, TrackWise and DMS/LMS is preferred

Language(s):

Dutch, English