Process Development Engineer

Proclinical is currently recruiting for a Process Development Engineer for a leading Pharmaceutical company located in Research Triangle Park, NC. As the Process Development Engineer, you will provide direct technical support to Engineering, Operations, and the Quality Unit, in order to achieve reliable and compliant manufacture of drug products (Rx and OTC).

Job Responsibilities:

• Responsible for providing technical support for the product and process development activities to enable the successful manufacture of semi-solid pharmaceutical drug products.
• Interacts with production personnel, equipment engineering and product development laboratory, Quality Assurance, in addition to providing assistance and direction for less experienced personnel.
• Execute assigned projects for the implementation of new processes, problem solving for existing processes, process optimization and supports process validation activities.
• Generate related documents including SOPs, batch documentation, protocols, development reports and investigations.
• Develop and execute design of experiments (DoE) to support the development and registration of manufacturing processes used to produce clinical and commercial products.
• Provide technical and operational support to meet customer commitments (internal and external).
• Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing.
• Understand the scientific principles required for the manufacture of semi-solids including the interaction of the chemistry, equipment, processes, and container closure systems.
• Investigate and resolve manufacturing issues that lead to production delays and technical issues with the product.
• Successful application of root cause analysis and systematic problem solving.
• Work within or lead cross-functional teams in positive fashion to implement manufacturing objectives and deliver on business plan and quality objectives.
• Attend and participate in process team meetings for production issues, resolution, and process improvements.
• Lead and/or participate as a team member on process improvements for the production area. These can include but not limited to experiments, modeling and/or production data analysis to improve process control, yield, purity, and/or productivity.
• Perform and summarize improvement opportunities in technical reports through statistical analysis, plant trials, investigations, research, lab trials, and process/unit operations modeling.

Skills and Requirements:

• 8 years plus prior experience working in a pharmaceutical environment.
• Bachelor's degree in a scientific discipline or equivalent experience (e.g. engineering, chemistry, biochemistry, etc.) / B.S. in Chemical Engineering is highly preferred.
• Technical/Scientific knowledge of solutions, semi-solids, topical and transdermal dosage forms is highly preferred. Has a functional understanding of the operation of production equipment involved in the manufacturing process.
• Excellent written and oral communication skills.
• Ability to work with Microsoft Excel, Word, Visio and PowerPoint.
• Demonstrated team participation and management skills required.
• Ability to use statistical tools such as JMP/Mini-Tab to evaluate the process capability of the manufacturing process.
• A clear understanding of ISO and cGMP regulations.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or m.jacobs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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