The companyOur client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands. A leading Pharma/biotechnology company who's mission is to discover and innovate medicines for patients with serious illnesses.
Role descriptionBecause of an increase in the Technical Transfer activities, we are looking for a young and ambitious professional to guarantee the correct device assembly, process monitoring and the international process transfer.
The Process Engineer will set the standards and ensure a good cross-functional communication between teams and countries.
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information Qualitative information, Quantitative research, Trends & data Forecasts, models, and utilizes advanced analytical tools
- Anticipates and prevents potential problems
- Creates new procedures and processes to drive improvements
- Handles diverse scope of issues that require evaluation of a variety of factors including current business trends
- Works under minimal direction
- Work is guided by operational and project objectives
- Manages multiple assignments and processes
- Independently determines approach to project
- May be responsible for specific programs and/or projects
- Independently develops solutions that are thorough, practical, and consistent with function objectives
- Contributes to work group/team by ensuring quality of tasks/services provided by self and others
- Provides training and guidance to others
- Extends capabilities by working closely with senior staff/experts within and outside the internal organization
Key responsibilities will include leading the Technical Transfer process for products, support in the design for manufacturability of all products. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The Engineer must ensure effective communication throughout the commercial site network with all stakeholders and deliver on technical improvements.
Act as the site subject matter expert for FPT combination products. Technical support for new process equipment and technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.
Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the sites by analyzing, designing, and implementing manufacturing and business process improvements.
The Engineer is expected to build a network of FPT expertise across the commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of the design for manufacturability of new combination products, performance trending of existing combination products, equipment standardization and troubleshooting/process improvements.
- Master’s degree and/or 2+ years of working experience in a GMP regulated environment
- Bachelor’s degree and/or 4+ years of related professional experience
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
- Proven track record of contributing to cross-functional projects
- Strong team work, excellent interpersonal and communication skills
- Experience with devices/combination products and the associated manufacturing process
- Experience of working with equipment suppliers
- Ability to work in a highly regulated and ever-changing industry
- Ability to learn and rapidly adapt to new requirements in a fast-moving environment
- An Operational Excellence approach to work product – driving rapid results
- A passion to deliver excellent work product, develop others with an infective positive attitude!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jorien van Es.