Role Overview: 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. Major Responsibilities: 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). Complete all other work associated with the assignment whilst working cooperatively with others Provide on call support as per operational needs is required Maintain knowledge of and compliance to all applicable codes and regulations as required. Obtain and keep current all required licensing, certifications and training associated with the job Perform minor upgrades to and support the implementation of new process equipment, instruments and systems 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 Available for other duties and demonstrate willingness to learn new skills as required Support the creation of new practices, policies and procedures (e.g., SOPs, Work Instructions, etc.) 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 Qualifications Education: Bachelor’s Degree in Engineering (Mechanical/Electrical/Bio) or any other related field or Equivalent Experience Required. Experience: 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. Key Capabilities, Knowledge, and Skills: Strong analytical, problem solving and critical thinking skills Transparent, passionate, responsible and accountable 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 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 Ability to pay attention to details and follow procedures Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint) Experience with SAP and CMMS is preferred Required: 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