Process Engineer II/Lead-OSD

Summary

This position will support and assist in manufacturing pharmaceutical products for commercial and clinical supplies.  Key duties include scale-up and transfer of oral solid dosage formulations/processes to the production facility, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols.   Troubleshoot automated equipment for pharmaceutical formulation and packaging.  Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes. Develop and implement SOPs in support of new and upgraded processes. Champion projects as they move into and through the manufacturing areas. Provide regular updates to leadership on project status and issues. 

Essential Functions

• Troubleshoot and maintain manufacturing systems, processes, and equipment. 
• Support the development or transfer of manufacturing and cleaning processes for the manufacturing area.
• "Hands-on" ability to install and troubleshoot instrumentation and equipment.
• Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
• Specify and size manufacturing systems, equipment, and process equipment.

Competencies

• Excellent communication and documentation skills
• Excellent organizational skills
• Ability to self-manage and prioritize workload.
• Ability to react quickly to understand and solve problems.
• Excellent troubleshooting skills
• Fosters collaborative relationships within and across groups through influencing and negotiation skills
• Positive attitude

Process Engineer II

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 2-5 year of manufacturing experience or technical experience.

Preferred Qualification:

• 2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience.
• Experience with OSD equipment procurement. 
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. 
• Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up. 
• Knowledge of OSD pharmaceutical process and equipment validations. 
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc

Lead Engineer I

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 5 year of manufacturing experience or technical experience.

Preferred Qualification:

• 5 years of OSD pharmaceutical experience.
• Experience with OSD equipment procurement. 
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. 
• Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up. 
• Knowledge of OSD pharmaceutical process and equipment validations. 
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc

Work Environment

Work will be split between the contained manufacturing area and the office.  

Physical Demands

• Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
• Ability to lift/move 40 lbs. overhead.  Ability to team lift up to 100 lbs.
• Must be able to be medically cleared for respirator use (PAPR)
• Ability to operate different types of production equipment. 
• Ability to gown correctly for clean room manufacturing operations.  
• Ability to stand or sit for extended periods (up to 2 hours at a time).  
• Must be able to work in an office and a manufacturing environment.  

Travel

<10%.

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