Process Engineer III

Job Description

The Process Engineer III provides expertise primarily in the area of pharmaceutical process engineering and technical transfer. This position will effectively manage large-scale projects and multi-disciplinary project teams. The process engineer will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. This individual will provide leadership and guidance to others.

• Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability.
• Oversee and assess existing processes and workflows.
• Establish and track process metrics to monitor process stability and discover areas for improvement.
• Technical Transfer of new products from both internal and external clients.
• Ownership of product process from initial quote to product retirement.
• Evaluate incoming processes for robustness, efficiency and fit within JHS‑Spokane.
• Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
• Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
• Develop and execute validation studies to test and qualify new and improved manufacturing processes.
• Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off‑shift at‑location support.
• Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes.
• Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.
• Participate in or perform deviation investigation and evaluation of impact.
  
  Implement effective CAPAs.
• Responsible for optimizing gross profit margin and minimizing deviation rate.
• Provide necessary reviews for regulatory and client audits and provide responses to audit observations.
• In-depth understanding of cGMP's, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
• Minimal travel (