Process Engineer

We're looking for a Process Engineer in order to reinforce our Commercial Product Introduction team (CPI).

As our Process Engineer, you areresponsible for the design of the manufacturing process of assay reagents, transfer of the process to operations as well as for routine manufacturing (Internal / External-CMO).

This role interfaces between development teams in house, prototyping/small scale operations in-house and production at CMO.

You arealso 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.

This role is part of the Commercial Product Introduction (CPI) Team and will require close collaboration with Procurement, Supply Chain, Assay Development and Quality Teams.

The responsibilities of our Process Engineerinclude, but are not limited to, the following (for internal or external operations) :

General:

• Provide technical guidance (SME) in relation to all manufacturing processes of assay reagents in the space of technology transfer as well as day to day operations;
• Understand biological aspects of production processes and their value in the complete functionality of the platform;
• 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;
• Complete regular assignments with minimum supervision.

New Product Introduction:

• Responsible for new product / assay implementations in close partnership with Assay Development, and quality groups;
• Take active part in the assay development by collaborating with scientists, and other engineers to ensure scalable solution by the time the assay is transferred to (Internal / External) Operations for commercialization;
• Lead and/or coordinate Design Transfer activities including process design, Process Documentation, DMR, Risk Assessment (pFMEA), Process Validation and start-up activities. Develop engineering documentation and processes for products with emphasis on following quality systems and rigorous documentation;
• Provide input in planning to the overall assay/product program.

Operations

• Provide remote and onsite technical troubleshooting. Understand and 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;
• 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.

• Master degree plus related work experience (3-5 years) with demonstrated expertise of specified functional area with knowledge of molecular biology (required) and sterile processes (asset);
• Experience with process design and process validation of assay reagents;
• Experience in cleanroom (required) and sterile environment (asset);
• Experience with working with or at CMO is also a significant asset;
• Ability to lead technical programs and initiatives, fostering collaboration among participants;
• Hands on attitude and drive to develop robust and manufacturing-compatible processes;
• Knowledge of Process Excellence (eg Six Sigma green belt);
• Technical writing skills with ability to author peer reviewed protocols and reports, production batch records, standard operating procedures;
• Proven ability to work in a cross-cultural environment and provide technical leadership while working remotely is a requirement;
• Excellent organization skills and ability to multi-task;
• 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;
• Entitled to live and work in Belgium. Our offices are located in Leuven area;