As our Lead of the Commercial Product Introduction (CPI) team, you will lead and coordinate the CPI group, bridging between the R&D teams and the commercial production process.
Your first priority will be to coordinate the IQ, OQ and PQ activities for all lab and cleanroom instruments, ensuring that the necessary documents are available before instruments are put in use (Safety and Risk analysis, installation requirements, work instructions, calibration and maintenance schedules, equipment inventory, …) and that the instrument’s Proven Acceptable Ranges are defined to ensure that any process developed on these instruments is well within these defined boundaries.
Your second priority will be to interact within the different R&D projects that make use of the production instruments mentioned above, with a strong Quality Engineering input, ensuring that the correct controls are put in place and that all developed processes are streamlined as much as possible.
A third priority will be a strong interaction with the Lab Coordinator to ensure that the equipment pool is kept online and functional.
Your responsibilities will be:
- Keeping track of all equipment, their status and required documents (Safety and risk analysis, installation, validation, maintenance record, calibration record and work instruction documents)
- Thoroughly understanding (production) processes and their value in the complete functionality of the platform
- Maintain an overview of the different processes and guard/work towards streamlining and uniformity
- Identify and troubleshoot process related issues
- Clear planning and reporting strategy
- Coordinate the IQ, OQ, PQ requirements and activities
- Aid in establishing release for manufacturing documentation (Risk and safety analysis, release for first manufacturing documents)
- 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
- Ensure that similar processes are aligned
- Maintain a strong quality focus on all developed processes with a clear goal for batch release and possible issue resolution
- Define a Key Process Engineer and Key Process Scientist for each instrument related to high scale production and support the Assay Development group with thorough process understanding on each of these production instruments to guarantee the development of a process that can be scaled to full production.
- Master in Applied Biological Sciences and Engineering or equivalent
- Chemistry and/or (Molecular) Biology knowledge is highly recommended
- Experience in IVD development and manufacturing is highly recommended
- Thorough knowledge of reading, writing and speaking English is a must
- 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
- Analytical and problem-solving experience 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.