Maintenance and Calibration Engineer
Belgium, Vlaams Gewest, LeuvenOperations
miDiagnostics is at the forefront of releasing its first product, an ultra-fast PCR test, into the market. This market introduction means rapid organization scaling and supporting the international growth ambitions of the company.
As our Maintenance and Calibration Engineer, you will be part of the Commercial Product Introduction (CPI) group, bridging between the R&D teams and the commercial production process.
You will be responsible to keep the (production) instruments up and running, perform scheduled maintenances and calibrations and crisis interventions. In addition, your input will be asked to improve future instrument designs regarding safety, accessibility for maintenance, spare parts and general functioning.
In addition, you will be responsible to maintain a critical parts inventory to support this maintenance assignment to ensure downtimes are minimal.
- Thoroughly understanding (production) processes and their value in the complete functionality of the platform;
- Maintain an overview of the different processes and work towards streamlining and uniformity;
- Develop a preventive/scheduled maintenance routine for (production) equipment in SciLife (supporting software);
- Develop and maintain accurate maintenance records for each instrument (SciLife);
- Maintain calibration status of all critical equipment (SciLife);
- Develop and maintain a critical parts list for each (production) instrument to ensure minimal downtimes;
- Identify and troubleshoot process related issues and feed these learning back into the second generation designs for future production instruments;
- Clear planning and reporting strategy;
- Understand the calibration aspects of processes;
- Assist in equipment validation (IQ, OQ, PQ);
- Capability to identify irregularities and possible improvements in processes;
- Safeguarding a structured approach towards problem solving;
- Clear communication within and across departments;
- Capable of transferring knowledge to colleagues;
- Daily focus on improvement.
- Professional Bachelor Electro-mechanics (option maintenance technologies) or equivalent by experience;
- Maintenance engineering background of at least 3 years on production equipment is a must (IQ, OQ, PQ, calibration, PAR, NOR, work instructions, reporting, risk and safety analysis, verification, validation);
- Chemistry and/or (Molecular) Biology knowledge is highly recommended;
- Experience in IVD development and manufacturing is highly recommended;
- Hands on attitude and drive to develop robust and manufacturing-compatible processes;
- Have passion and enthusiasm for developing new products & processes;
- Thorough knowledge of reading, writing and speaking English is a must. Knowledge of Dutch is a strong asset;
- Good communication and presentation skills are a must;
- Team player attitude;
- Office knowledge is a must;
- RATIO approach to problem solving is a plus;
- Cleanroom experience is a plus;
- Knowledge of silicon chip technology is a plus;
- Knowledge of Process Excellence (Six Sigma black belt certified) is a plus;
- Strong analytical and problem-solving experience is a plus;
- Programming skills is a plus;
- You feel comfortable in a start-up environment and you can easily switch from one task to another;
- You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues;
- Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.