Periode: Direct hire
Our client is a leading Project Management and Engineering Company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide Full Service Engineering for their clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors.
The Tech Transfer Officer is responsible for assisting with the transfer of manufacturing processes and/or technology from R&D to the plant manufacturing plant. He/she participates in designing manufacturing procedures for new or modified products, planning, coordination, and oversight of the manufacture of development, product validation batches, and cleaning validation/verification studies as needed, and providing technical support to manufacturing operations as assigned by Project Manager.
- Coordinates the preparation for the manufacture of the new products to ensure smooth preparations for and executions of batch manufacturing;
- orders required project-specific materials, co-prepares master batch records, product specification files, and testing plans for the manufacture of development, validation and launch batches, as required;
- communicates plant issues and tasks with the project team with respect to readiness for process scale up, new equipment and procedures, equipment and process validation and manufacturing of batches;
- serves as the plant focal point for channeling all manufacturing related questions and regularly supervise/participate in manufacturing operations.
As required, provide or review various technology transfer documentation, and leads/organizes production deviation investigations.
• Evaluate new technologies to improve/optimize commercial manufacturing processes
• May fulfill other jobs/responsibilities
- Minimum of a Master’s degree in pharmacy, engineering, or equivalent experience;
- must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
- fluent command of the English language and at least basic command of the Dutch language;
- 1-3 years’ experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion; analytical skills necessary for problem solving issues as they arise;
- lnowledge of parenteral product development, manufacturing processes, validation, cGMP’s and FDA regulations for the Pharmaceutical Industry