Process Development Engineer

Job Description:

Process Development Engineer is responsible for designing and implementing processes for development products. The Engineer will design and implement appropriate change requests, packing studies, batch records, forms, procedures, work instructions, risk assessments, etc. as needed to achieve the development and production goals of the organization.

The Engineer’s responsibility will include Formulation, Filling, Bulk and Finished Packaging development as assigned by management. 

Responsibilities:

• Development of manufacturing processes for new products.
• Creation of User Requirement Specification for purchasing of Service and Equipment.
• Creation of Process and Product Characterization Studies for manufacture of Solutions, Emulsion, and Suspensions.
• Create and execute process development activities related to the batch manufacturing including process sampling, and studies of equipment capability, cleaning cycles, and sterilization cycles.
• Write Product Development Summary Reports of studies, risk assessments, etc.
• Investigating Process Failures to include Root Cause Analysis and recommended corrective and preventative actions.
• Development of Cleaning Limits and support of equipment cleaning studies when required.
• Filter Validation when required.
• Coordinate shipping studies with customers and qualified testing laboratories.
• Prepare summary reports detailing procedures and test results upon study conclusion.
• Technology Transfer from the Development to the Commercial phase of the product life cycle.
• Familiar with FDA and EU GMPs, ICH Q8, Q9 and 10, ISO Clean Room Standards, ASME BPE Standard.
• Follow Standard Operating Procedures, safety and cGMP Guidelines.
• Perform tasks as directed by the Sr. Director, including but not limited to the above responsibilities.

Qualifications:

• Four-year degree in Chemical or Mechanical Engineering
• 1-3 years of experience in Pharmaceutical manufacturing or other regulated manufacturing experience a plus.
• Strong interpersonal/group communication skills
• Proficient with MS Office products, Visio and CAD