Looking for Successful Leaders
The Process Engineer is responsible for supporting production in the manufacturing of drug product tablets and capsules to meet quality requirements and on-time customer delivery. This position is also responsible for supporting the technical transfers and scale-up to cGMP manufacturing for new products. This includes developing and executing strategies for new equipment qualification and process/cleaning validation.
- Develop/revise/review documentation (protocols, in-process sampling forms, reports, Master Formulas, SOP’s, Master Plans, etc.) to support product/process development and submission, site transfer, validation, equipment qualification and packaging studies.
- Assist with investigations to identify and rectify root causes of batch discrepancies or failures.
- Participate in project teams and develop project timelines.
- Coordinate the training of operations personnel on new technology, equipment or processes to assure successful transfer from research to operations.
- Assist Operations and QA personnel on new products/processes/equipment in order to successfully manufacture batches.
- Develop and implement process improvements to increase productivity in response to ever changing business needs.
Minimum B.S. in Pharmaceutical Science, Engineering, Technology or equivalent. 2-5 years of Pharmaceutical Manufacturing or Technical Services/Validation/Process Development related experience.
- Solid Dose Manufacturing.
- Process Validation.
- Equipment Qualification.
- Experience in running and setting up compression, blending, granulation, coating, drying and encapsulation equipment at both a Pilot and Manufacturing scale FDA cGMP regulations Working knowledge of cGMP’s and SOP’s is essential.
- Effective written and verbal communication skills.
- Strong computer skills including Word and Excel.
- Good analytical, problem solving, organizational and training skills.
- Experience with capital projects; including facility, equipment design, installation, and qualification.
Minimum 2 Years of Pharmaceutical Manufacturing.