Process Engineer

**Summary:**

This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost effective solutions for manufacturing.

**Job Duties:**

1. Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures.
2. Produce APIs and intermediates according to preapproved instructions;
3. Review all production batch records and ensure that these are completed and signed.
4. Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded).
5. Ensure that production facilities are clean and disinfected;
6. Ensure that all necessary calibrations are performed (with records kept)
7. Maintain the premises and equipment (with records kept).
8. Ensure that validation protocols and reports are reviewed and approved;
9. Evaluate proposed changes in p...