503B Process Development Engineer - Formulation at The Ritedose Corporation in Columbia, South Carolina

Job Description:

The 503B Process Development Engineer - Formulation is responsible for designing and implementing dispensing and formulation processes for 503B drug products.   The Engineer will create appropriate change requests, formulation and filling studies, batch records, forms, procedures, work instructions, risk assessments, cleaning verifications and validation, etc. as needed to achieve the development and production goals of the organization.

Responsibilities:

• Purchase of goods and services.


• Product Development Life Cycle, Planning, Initiating and Development.


• Ensuring new or revised manufacturing process follow cGMP.


• Create or revise new product documentation as required such as development plans, lab batch protocols, process flows, procedures, work instructions, batch records, and bill of materials.


• Equipment Cleaning Assurance – Cleaning Lifecycle, Concepts of Cleaning, Determination of Cleaning Limits, Cleaning Cycle Studies and Verification, and Cleaning Agent Determination.


• Create process studies for drug product formulation.


• Work with internal and external experts to assist in the development of product specifications, testing requirements, and process descriptions.


• Perform process Failure Mode and Effects Analysis, Critical Process Parameters and Critical Quality Attribute assessments.


• Coordinate resources towards completion of tasks assigned in the project management plan.


• Execute process development studies related to the batch manufacturing including process sampling, and studies of equipment capability, cleaning cycles, and sterilization cycles including summary reports.


• Follow Standard Operating Procedures, safety and cGMP Guidelines.


• Perform other tasks as directed by the Management including but not limited to the above responsibilities.

Qualifications:

• Four year degree in Chemical or Mechanical Engineering, Science, or directly related field


• 5 years manufacturing experience


• 503B manufacturing / pharmaceutical manufacturing experience is preferred 


• Strong interpersonal/group communication skills


• Proficient with MS Office products, Visio and CAD