Process Engineer

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

• Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures.
• Produce APIs and intermediates according to preapproved instructions;
• Review all production batch records and ensure that these are completed and signed.
• Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded).
• Ensure that production facilities are clean and disinfected;
• Ensure that all necessary calibrations are performed (with records kept)
• Maintain the premises and equipment (with records kept).
• Ensure that validation protocols and reports are reviewed and approved;
• Evaluate proposed changes in product, process or equipment.
• Responsible for ensuring that new and modified facilities and equipment are qualified.
• Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes.
• Manage assigned projects in order to complete each project on time, under budget and within the design parameters.
• Provide training for API processes.
• Other duties as assigned.

• BS in Chemical Engineering.
• 5 years experience with FDA/GMP. Experience with DEA guidelines and regulations a plus.
• Ability to present ideas effectively to all levels of management.