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.

Responsibilities

  • 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.

Requirements

Minimum B.S. in Pharmaceutical Science, Engineering, Technology or equivalent. 2-5 years of Pharmaceutical Manufacturing or Technical Services/Validation/Process Development related experience.

Preferred 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.

Required Experience

Minimum 2 Years of Pharmaceutical Manufacturing.

Required Education

Bachelor’s Degree

Job Type

Full-time

If you’re interested in joining a diverse team where you can make a difference, please contact us at

careers@tedor.com

Start typing and press Enter to search