assets maintenance & calibration mananger.

In your role as Assets Maintenance & Calibration Manager you are responsible for providing technical in-depth expertise, leveraging best practices, oversight and developing internal as well as external partnerships with focus on Maintenance and Calibration (M&C) within the CAR-T EMEA program serving the Beerse and the Ghent sites. The role will oversee the day-to-day business of M&C activities and ensure flawless liaison with the different teams, vendors, sites, and stakeholders. In addition, the role holder creates and sustains continuous procedural improvements to boost efficiency of M&C activities. The ideal candidate will possess a strong track record in manufacturing asset maintenance as well as calibration, business acumen, proactive communication, and a willingness to be hands-on in key aspects of M&C tasks. The role requires the development of strong partnerships and strong interfacing with Operations, Quality, Environment Health & Safety as well as 3 rd party partners.

Your tasks and responsibilities are:

• Ensures flawless execution of planned preventive and corrective maintenance and calibration activities for manufacturing and laboratory equipment as well as facilities and utilities.
• Drives the establishment of a holistic, balanced RCM-based M&C strategy across the asset portfolio including the translation into execution and continuous improvement.
• Ensures that technical issues or roadblocks are anticipated and resolved as early, and as fast as possible incl. lessons learned.
• Supports investigations, corrective and preventive actions towards successful timely and compliant closure.
• Ensures M&C activities follow all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate and technical standards.
• Provides technical leadership and act as a true expert for M&C.
• Participate in compliance inspections/audits within area of responsibility Manage partnerships with contractors and vendors.
• Establishes and manages KPI’s and tracking tools across the scope.
• Actively communicates regularly with project leads and project delivery stakeholders.
• Responsible for supervising engineers and specialists at the sites by driving a Credo-based culture aligned around our guiding principles of servant leadership, Think Differently, Do Better, innovation, engagement, collaboration and development.

• Degree in Engineering (Masters preferred)
• 8-10 years of experience in pharmaceutical (or chemical) plant based or service provider role
• A minimum of 5 years in leading maintenance and calibration activities
• A minimum of 3 years in executing maintenance and calibration activities
• Previous exposure to international health authority inspections as well as internal and external audits
• Self-driven and able to set own targets and able to set priorities under pressure
• In depth knowledge of guidelines and codes related to equipment, utilities and facilities (e.g. ISO, EN, ISPE) and applicable current GMP requirements (e.g. ICH, FDA, FAGG/FAMHP)
• Previous experience working in a large matrix-managed environment preferred
• Previous in-depth experience with SAP/PM is a must
• Fluent in English (written and spoken), Dutch language at level C1 preferred
• Proactive, open team player with a service mindset
• Working regime is approx. 60% Ghent, 30% Beerse, 10% travels.
• Presence on both sites is required.

Unique environment where you will be working on the innovative side of cancer control.
You work in a high-tech company (clean room environment) and participate in a plant that is in its start-up phase, which means you can learn a lot and take on a wide range of responsibilities (project follow-up, engineering, trouble-shouting, etc.).
Besides this, you will have a lot of social contact with colleagues and external parties that you follow up.
In addition to all this, you will receive a stimulating remuneration.

If you feel attracted by this challenge and want to be part of a successful and growing organization with excellent working conditions then please send me your online application.
Would you like more information? Feel free to contact me: eveline.bracke@rss.randstad.be