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 product, process or equipment.
10. Responsible for ensuring that new and modified facilities and equipment are qualified.
11. Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes.
12. Manage assigned projects in order to complete each project on time, under budget and within the design parameters.
13. Provide training for API processes.
14. Other duties as assigned.

Education, Experience & Competencies

1. BS in Chemical Engineering.
2. 5 years experience with FDA/GMP.  Experience with DEA guidelines and regulations a plus.
3. Excellent organization skills.
4. Ability to present ideas effectively to all levels of management.