Process Engineer

Job Description:

Seeking an experienced Process Engineer to join our team. This position will provide support and assistance in the manufacture of pharmaceutical products for commercial and clinical supplies. Key duties include: scale-up and transfer of oral solid dosage formulations/processes to production facility, design and recommend equipment purchases, write and execute 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. 

Qualifications:

Bachelor’s degree; scientific discipline including Engineering or equivalent field. Minimum of 2+ years working experience in oral solid dose pharmaceutical engineering experience or 5+ years pharmaceutical engineering experience. 

Technical Knowledge/Skills Needed:

*Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.

*Thorough knowledge of automated control systems. 

*Thorough knowledge of computer systems operation and software. 

*Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. 

*Thorough knowledge of chemistry, statistics, equipment design, process control and process scale-up.

*Knowledge of oral solid dose pharmaceutical operations and equipment validations. 

*”Hands-on” ability to install and troubleshoot instrumentation and equipment. 

*Ability to troubleshoot and maintain manufacturing systems, equipment and processes. 

*Ability to author high quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications and SOPs. 

*Ability to specify and size manufacturing systems, equipment and process equipment. 

*Ability to gown for clean room operations. 

*Ability to read, understand and accurately follow company SOPs and guidelines.

Location 

Midwest

Consultant 

Andy Ellis