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 Production Engineer within Life Sciences, you have a strong interest in pharmaceutical production processes and aseptic techniques. You love to learn (and keep learning) about the manufacturing process and want to become an equipment or process specialist.
With a focus on production equipment, your main tasks are to implement and validate the production equipment and production lines to be used, all the way from the design phase to final release and use in commercial production. Taking into account a detailed risk analysis, you work out a project planning, including the feasible timelines and budget planning. Furthermore, you are responsible for executing the project plan in a GMP compliant way. You have technical know-how and offer support in analyzing and solving technical problems.
With a focus on the process, you are responsible for the design, validation, and final release of the pharmaceutical production process for commercial purposes. You ensure that these activities are performed according to the current quality requirements and you reach out to all involved stakeholders (QA, Production, Laboratory...) in a timely manner. Moreover, you are also the point of contact for the implementation of process improvements and for follow-up actions arising from deviations and CAPAs.
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 already have experience in a pharmaceutical manufacturing environment.
- You have affinity with IT and automation systems (PLC, SCADA, MES, ...) and have a technical mindset.
- You are good at analytical thinking, prioritizing and planning.
- You are not afraid to take the lead.
- 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.
- 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.