Ordina is the digital business partner that uses technology and market knowledge to give its customers an edge. We help our customers stay ahead of change through smart digital end-to-end solutions, sustainable software solutions and the design and management of IT landscapes.
As a Manufacturing Execution System (MES) Engineer, you will be jointly responsible for increasing efficiency and reducing risks within production processes. Your knowledge of MES PAS-X, Delta V, Siemens or another known system, combined with your general process knowledge within Life Sciences, will help you to estimate and implement optimizations in communication with QA and production. Moreover, you always take into account the GMP regulations and company procedures. Technical insight and an eye for detail are certainly among your core qualities.
Your responsibilities include:
- You are responsible for creating and maintaining recipes for the automation systems in Delta V Recipe Studio or PCS7 Simatic Batch.
- With process changes or the implementation of new processes, you prepare control recipes and ensure that they are always in line with the Master Batch Records.
- You are the point of contact for technical projects and help think about the improvements that can be implemented.
- You work closely with your team and regularly consult with the various stakeholders: process engineer, production and QA.
- You ensure compliance with procedures and regulations
Where you're going to get started
Ordina's Quality & Compliance (Q) team provides more than 100 expert consultants in 3 different practices, Laboratory, Production and Business Technology. Within these practices different roles are taken up by the Q&C engineers such as qualification and validation of equipment, production lines, cleaning, sterilization, utilities, software’s as well as business analysis, engineering, building, project management and so much more. Most of the Q'ers have a scientific background; often industrial engineers, bioengineers, biotechnologists, biomedical scientists, pharmacists, ... but historians, translators/interpreters, communication scientists, etc. also regularly find their way to our team.
This is you
- Graduate with a Master's degree in a scientific direction (Industrial Engineer, Bio Engineer, Chemistry, Biotechnology, Pharmacy,...) or equivalent by experience.
- Familiar with regulatory standards and guidelines (GAMP5, EU Annex 11, 21CFR Part 11, ISO9001...) and concepts such as QMS, Data Integrity, CAPAs, GDPR,...
- You have already experience with Delta V in the pharmaceutical sector.
- You have affinity with IT and automation systems (PLC, SCADA, MES, ...).
- You can keep an overview and are good at planning and setting up structures.
- You are quality and customer-oriented.
- You have strong administrative skills, are punctual and have an eye for detail.
- Strong sense of responsibility and accountability.
- Excellent communication skills in Dutch and English.
- You will contribute to projects for top companies, both nationally and internationally.
- You will work in an exciting environment with a focus on knowledge and innovation.
- Your colleagues are pragmatic professionals, open to new ideas and initiatives.
- You keep your knowledge up to date by participating in trainings, workshops, competence centers and conferences.
- You are in the driver’s seat of your career.
- You enjoy benefits such as a company car, laptop, phone allowance, insurance, etc.
Everyone is welcome to apply. At Ordina, we believe in the power of diversity and value inclusion. After all, a mix of mindsets provide the best ideas and smartest solutions. That is exactly why we pay so much attention to the composition of our high performance teams. So you feel at home and can get the best out of yourself.