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- Plymouth, MN
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Pilot Plant Engineer - Pharmaceutical Development
Pace Analytical • Plymouth, MN
Posted 19 hours ago
The process engineer supports activities related to the enhancement of existing products/processes and implementation of new product launches including execution of process validation. The ideal candidate will have experience in technical transfer of solid oral dose pharmaceuticals, technical writing, process validation, process engineering, and manufacturing experience. Manufacturing equipment knowledge is a big plus.Responsibilities
- Supports monitoring, investigations, engagement of scale-up or post approval changes to support existing products
- Assist in the coordinated activities with product development for new product scale-up and manufacturing ANDA submission batches
- Contributes to oral dosage formulation process development, process scale up and technology transfer to commercialization throughout the product life cycle
- Support change requests for resolution of production issues and deviations to ensure supply and business continuity
- Supports scientific studies to investigate exception occurrences, atypical observations, change control proposals and customer complaints
- Understands and supports the activities associated with the operation of pilot scale & commercial pharmaceutical manufacturing equipment without supervision
- Evaluation of formulation and process to determine their effects in relation to final product specification
- Participation in formulation process evaluation and participate in project risk assessments
- Supports the design, plan and execution of scale up and robustness evaluation of formulation processes
- Conducts evaluations and experimental studies designed to develop and optimize existing product formulations and manufacturing processes under supervision
- Present conclusions with clear, logical, scientific explanations and justifications via technical report
- Support internal, external and regulatory inspections including FDA, EMEA, and third party inspections
- Bachelor’s degree in Engineering and 4+ years of experience working in the pharmaceutical industry OR Master’s degree in Engineering and 2+ years experience working in the pharmaceutical industry
- Experience working with solid oral dosage forms strongly preferred
- Experience working with formulation process development, process scale up, technology transfer, or ongoing commercial product support preferred