Senior Process Engineer - CPI team
Belgium, Vlaams Gewest, LeuvenOperations
As our Senior Process Engineer, you will be part of the Commercial Product Introduction (CPI) group, bridging between the R&D teams and the commercial production process.
As a CPI Senior Process Engineer, you will be key user of several instruments for which you will be responsible to perform the IQ, OQ and PQ, write work instructions, perform risk and safety analysis and help the R&D teams to use the equipment in the most optimal way.
In the CPI Senior Process Engineering role, you will be an active part of at least one project team developing an assay, in the same way a project manager or a quality person assists the team in accomplishing its goals. In this way you will be able to capture lessons learned and the history of the assay by the time it is transferred to the CPI group for commercialization. You will be responsible for the design transfer to operations, the assay specific process development and process validation.
As a CPI Senior Process Engineer you will be responsible for the equipment management process, process validation process, the design transfer and device master record process. You will coach and support your colleagues in the execution of these processes.
Your responsibilities will be:
- Thoroughly understanding (production) processes/equipment and their value in the complete functionality of the platform
- Maintain an overview of the different processes/equipment and work towards streamlining and uniformity
- Identify key process/equipment parameters and define optimal working range and outer boundaries (PAR, NOR)
- Identify and troubleshoot process/equipment related issues
- Define acceptance parameters of equipment (IQ, OQ, PQ)
- Define stable and capable manufacturing processes (process development, validation, risk analysis)
- Establish design transfer documentation (device master record)
- Take ownership of related processes and define improvements
- Coaching team members on technical aspects
- Define Key Performance Indicators and trending of these parameters
- Safeguarding a structured approach towards problem solving
- Clear planning and reporting strategy
- Clear communication within and across departments
- Masters’ degree in Bio-Engineering or equivalent
- Process engineering background of at least 5 years on production equipment is a must (IQ, OQ, PQ, calibration, PAR, NOR, strategy, protocols, work instructions, reporting, risk and safety analysis)
- Experience in IVD development (design transfer) and manufacturing process development and validation is of at least 5 years is a must
- Experience in technical coaching of scientific profiles is highly recommended
- Experience in packaging engineering and labelling is a plus
- Chemistry and/or (Molecular) Biology knowledge is highly recommended
- Knowledge of silicon chip technology is a plus
- 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
- Good communication and presentation skills are a must
- Team player attitude
- Capable of transferring knowledge to colleagues
- Office knowledge is a must
- Strong analytical and problem-solving experience is a highly recommended
- Knowledge of Process Excellence (Six Sigma black belt certified) 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.