Secondment with contracting
Food, Feed, Pharma
About this vacancy
Welcome in our team
The role of Biotech Process Engineer is situated in the Process Support Team of IPT DSP. Process Support is responsible for Master Manufacturing documentation (MBRs, automation recipes, etc.), shopfloor support and first-line trouble-shooting. The team of about 18 people consists of Biotech Specialists (two sub-teams with different product-focus, fertility and oncology), cleaning validation engineers and an MES (PAS-X) engineer.
Primary tasks/ responsibilities
- Shop floor support for our large-scale processes;
- First-line troubleshooting of clinical and commercial products;
- Coordinate and resolve Quality Notifications (deviations);
- Define and implement effective CAPA’s and process-related changes;
- Write and improve batch documentation (Process Prescriptions, Batch records & Unicorn/Pall/MES/SAP recipes);
- Assists/writes validation reports (e.g. medium hold qualification, PPQ), Continuous Process verification reports, campaign summary reports;
- Continuous process surveillance using KPIs and data trending (e.g. Minitab, OSI-PI)
- Support technology transfer of new products, including facility fit, equipment selection and process transfer and qualification;
- Execute improvements in business processes, leveraging lean six sigma and/or Kata mind-set;
- Assists or lead training of IPT operators on unit operation execution of new process.
A multinational pharmaceutical company founded over 130 years ago, is mainly focused on medicines, vaccines, biologic therapies and the development of animal health products.
YER Technology offers you the possibility to join as Engineering Professional and to combine challenging assignments with extensive application and career guidance. The following conditions are applicable:
- Attractive salary according to the standards of our clients;
- 25 holidays per year and the option to buy more holidays;
- A temporary or permanent contract with YER;
- The possibility to join (y)our client directly after one year;
- Travel expense reimbursement;
- Good pension scheme according to STIPP;
- Every hour of overtime will be compensated;
- Open and transparent communication with your personal consultant;
- Free Dutch classes;
- Personal career coaching from our occupational psychologists;
- Broad technical and softs skills training opportunities;
- A Service Desk ready to answer all your practical questions.
- Minimum BSc in Biotechnology, Biochemistry, Engineering or equivalent;
- Minimum of 2 years of experience in Biotech Processing (highly preferable);
- Go to gemba mentality and practice;
- Experience in Root Cause Analysis and facilitate Lean Six Sigma tools (preferable);
- Experience with authoring electronic Master Batch records (e.g. in MES/PAS-X) (preferable);
- Must have a high standard for compliance, GMP and EHS;
- Up to date with scientific and technological developments;
- Analytical and organizational mindset;
- Project Management skills (preferable);
- Strong people and communication skills to communicate with all layers of the organization;
- Excellent verbal and written communication skills in both Dutch and English.