Maintenance Engineer English

This position will be part of the Engineering and Maintenance team within the Technical Operations group and will be responsible for performing on-site reactive, preventive and predictive maintenance activities through safe and compliant manufacturing operations according to cGMP requirements in the Clinical and Commercial Cell Therapy Manufacturing facilities. This role will require 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.

Perform on-site reactive, preventive and predictive maintenance activities (e.g., work orders, safety inspections, day-to-day equipment and systems support) in compliance with production schedules and all company and/or site policies and procedures
Investigate, troubleshoot, repair and maintain all types of process equipment, instrumentation, systems, electrical devices, circuits, controls, switch gear and motors used in cGMP and non GMP areas
Properly and timely document all maintenance activities in the computerized maintenance management system (CMMS) utilizing good documentation practices (GDP). Obtain and keep current all required licensing, certifications and training associated with the job
Support tracking and achievement of annual Engineering and Maintenance objectives including metric improvement targets
Implement or propose alterations, modifications, or replacement of existing equipment and systems to improve reliability and reduce maintenance costs and downtime
Identify and provide support for the implementation of new and innovative cost & quality improvement initiatives for the successful development of business opportunities as required
pertaining to Engineering and Maintenance activities to enhance the performance of the business
Support Engineering and Maintenance driven quality events including (but not limited to): Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, CAPAs, Root Cause Analysis and FMEAs

Bachelor’s Degree in Engineering (Mechanical/Electrical/Bio) or any other related field or

A minimum of two (2) years of experience in maintenance, engineering or operations within an industrial manufacturing or regulated environment is required. Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions is preferred.

A good understanding of technical installations, process equipment, facilities and computerized systems within an industrial manufacturing or regulated environment
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 read and interpret technical English, equipment manuals and complex mechanical, pneumatic and electrical blueprints
Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
Ability to accommodate changes in the schedule including working in other shifts and providing on call support as per operational needs is required
Highly organized and able to work independently and effectively in a team environment with a positive attitude with minimal guidance/oversight
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
Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint)
Experience with SAP and CMMS is preferred

In this position you will be required to work in a shift regime : Early, Late and frequently in weekend, We can provide more info on the specific regime during our first contact.

Language:
Dutch, English