This position is part of the Engineering and Maintenance organization within the Technical Operations group and is responsible to ensure that all production process assets for the GMP Clinical and Commercial Cell Therapy Manufacturing facilities in Ghent (Belgium) are properly maintained, and all on-site reactive, preventive and predictive maintenance activities are planned and performed in compliance with production schedules.
Your Responsibilities:
Develop and oversee the planning and execution of Engineering & Maintenance activities for production process equipment (e.g., calibration, certification, qualification, reactive and preventative maintenance activities)
Ensure that all production process assets are properly maintained and all on-site engineering & maintenance activities are planned and performed in compliance with production schedules
Closely work together with Maintenance & Engineering colleagues 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
Responsible for the technical content and administrative preparation, planning and follow-up of preventative and corrective maintenance activities
Making appointments with the user and scheduling to provide access to assets for execution of maintenance & engineering activities
Coordination with and administrative follow-up of third parties in the event of outsourcing maintenance activities
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
Ensure contractor and vendor completed work and related documentation meets the necessary maintenance standards and is handed over appropriately
Lead/support the conclusion of Engineering and Maintenance related quality events including (but not limited to): Notifications, Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, CAPAs, Root Cause Analysis and FMEAs
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
Support tracking and achievement of annual Engineering and Maintenance goals and objectives including metric improvement targets
Report performance metrics (e.g., equipment mean time to repair and mean time to failure) and provide/execute corrective action plans
Develop new systems, practice
Profile
In order to take up this challenging role:
Proven planning capabilities. 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 colleagues
A good understanding of technical installations, process equipment, facilities and computerized systems within an industrial manufacturing or regulated environment
Working knowledge of process equipment and instrumentation
Familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory
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
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
Experience with SAP, CMMS and TrackWise is preferred