Senior Process Engineer (External Manufacturing)
Belgium, Vlaams Gewest, LeuvenManufacturing and Supply Chain
As our External Manufacturing Senior Process Engineer you are responsible for the manufacturing process, transfer of design as well as for the routine manufacturing of the miDiagnostics Reader device (PCR reader) at external contract manufacturing organization (CMO) site. This role will support all technical aspects of the Product working closely with our Product Development team who own the design.
You are also responsible for achieving efficient manufacturing operations, monitoring/delivering KPIs, supporting manufacturing deviations, managing change impact evaluations and technical documentation reviews, driving continuous process improvements as well as driving capacity expansion projects. You will also provide inputs to the strategy for near-term and long-term product demand and capacity for the products, processes and technologies in scope.
This role is part of the Commercial Product Introduction (CPI) Team and will require close collaboration with our Product Development and Quality Teams.
These include, but are not limited to, the following
- SPOC person representing all process engineering function in the space of day to day operations and project execution;
- Responsible for process and technology transfers, change management, and provide technical process support for routine commercial products at the CMO;
- Partner with Product Development team to develop and enhance “Design for Manufacturing” (DFM) and Quality by Design (QbD). This includes efforts to document current processes, continuous improvement of the process and experiences generated in end-to-end operations;
- Responsible for new product implementations in close partnership with Product Development, and Quality groups. Coordinate validation and start-up activities that may include providing process training to support implementation of new technologies and specifications as well as process changes;
- Responsible to achieve efficient routine operations which can include:
- Real time process monitoring and data analysis trending in partnership with manufacturing
- Understand process variability and robustness on the floor to provide proactive and early observation of negative process trends and looks to eliminate or mitigate potential future performance challenges
- Understand and constantly track manufacturing and quality’s “day to day” challenges to ensure best support and allow improved performance anywhere in the production cycle. Work to improve yield, increase process robustness, reduce costs, improve cycle times, improve throughput capacity, work toward zero deviation strategy
- Being the process owner and “eyes and ears” on the floor in routine production and engages prod development function effectively
- Provide remote and onsite technical troubleshooting support for manufacturing activities at external manufacturing locations when needed;
- Assist with creation and revision of technical documentation (e.g. changes controls, SOPs, and batch records) as well as support deviation investigations and corrective and preventive actions (CAPA) as a technical resource;
- Leverage and maintain strong relationships with external partners and partner with the procurement lead to ensure contract fulfillment;
- Deliver communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration;
- Foster innovative behaviours and strong inter-team relationships to achieve improvement goals;
- Complete regular assignments with minimum supervision.
- B.S. with 7+ years or more experience working as Process Engineering, Operations in Medical / Diagnostics/ Healthcare industry with experience in equipment and/or assembly manufacturing. Preferred specialties are: Mechanical, electronical and automation;
- Experience with working with or at CMO is a significant asset;
- Experience in regulated GMP manufacturing environments;
- Strong interpersonal and leadership skills to work with internal and external teams in different functions and organizations;
- Experience in Process Excellence (Six Sigma green belt certified);
- Technical writing skills with ability to author peer reviewed protocols and reports, production batch records, standard operating procedures;
- Ability to complete projects and tasks in partially remote setting without face-to-face supervision;
- Ability to function effectively in a regulated work environment by navigating and complying with Standard Operating procedures and quality management processes;
- Demonstrated proficiency with effective and proactive written and verbal communication appropriate for technical and regulated work environment;
- Excellent organization skills and ability to multi-task;
- Excellent knowledge of English;
- You thrive in a fast-paced and changing environment, you are a real entrepreneur;
- You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues;
- You are entitled to live and work in Belgium;
- Ability to travel up to 30-50%.