Process Development Engineer​/Scientist

#2642 Process Development Engineer / Scientist

Our client is a global presence in the development and commercialization of generic and novel pharmaceutical products.

This professional will be responsible for transfer and validation of new products/processes into production, scale-up/ manufacturing development, product transfer, and optimization. The major objective is to ensure successful new product transfer to production and proper training of production personnel in any new process and/or equipment.

Key objectives include troubleshooting and reformulation of problem products, providing technical expertise and support to production Quality investigations. Other key objectives include generation, execution, and reporting of products, cleaning, and equipment validation protocols. Additional objectives include new production equipment selection and evaluation, rework evaluation of rejected batches and new/existing raw material evaluation.

• Coordinate the scale-up batches of new products and processes including batch record preparation, scheduling, raw material acquisition, supervising batch manufacture, etc.
• Identify potential product/process improvements of existing commercial dosage forms. Present proposals to optimize formula and product flow and implement changes after management approval.
• Responsible for development of potential product/process activities for new products. Will present proposals to optimize formula and product flow.
• Provide technical assistance to Production as needed to solve problems on the shop floor. This includes troubleshooting of active products and potential rework procedures for failed batches.
• Responsible for new equipment evaluation. Interface with engineering and equipment manufacturers to ensure proper installation and operation of the new equipment. Coordinate all activities to transfer new equipment to production, including training supervisors and operators.
• Evaluate and qualify alternate sources of raw materials.
• Maintain compliance with Controlled substance documentation and accountability procedures while maintaining high level of diversion and theft possibilities.
• Coordinate, develop and prepare protocols for process/product validation studies, including cleaning and equipment validation.
• Prepare validation reports including data analysis, conclusions and recommendations.
• Coordinate the execution of validation studies with production scheduling. This may also include review and execution of protocols developed by other individuals.
• Perform other related assignments and duties as required.

• BS degree in Chemistry, Biology or Engineering with a minimum of 5-7 years experience in Pharmaceutical Product Development and/or Process Development;
  Master’s degree and 4 years experience.
• Advanced knowledge of process development methodologies, including current validation concepts, with a strong working understanding of cGMP requirements and FDA and DEA regulations.
• Demonstrated expertise in the operation and oversight of pharmaceutical production equipment, including high‑shear granulators, fluid bed processors, solution preparation systems, weighing and dispensing systems, milling and blending equipment, tablet compression machines, and encapsulation systems.