Senior Process Engineer - Weekdays

Job Description

The Senior Process Engineer provides expertise in pharmaceutical process engineering and technical transfer. This position manages large‑scale projects and multidisciplinary teams, provides technical direction for complex projects, and exhibits superior communication skills with all levels of employees. The engineer refines department and site processes while providing 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 stability and discover improvement opportunities.
• Conduct technical transfer of new products from internal and external clients.
• Own product processes from initial quote to retirement.
• Evaluate incoming processes for robustness, efficiency, and fit within JHS‑Spokane.
• Perform development work to define CPPs and CQAs for strong execution upon transfer to manufacturing.
• Author validation study documents demonstrating consistent product quality.
• Develop and execute validation studies to qualify new and improved manufacturing processes.
• Troubleshoot, oversee, and sample events within manufacturing; occasional off‑shift onsite support required.
• Generate reports summarizing study results; use data to qualify site processes.
• Review data summaries from other departments, assess trends or conditions that may impact quality, and ensure corrective actions are implemented.
• Participate in or perform deviation investigation and evaluation of impact.
• Implement effective CAPAs.
• Optimize gross profit margin and minimize deviation rate.
• Provide necessary reviews for regulatory and client audits and provide responses to audit observations.
• Maintain in‑depth understanding of cGMPs, European regulatory requirements, USP chapters, and scientific principles associated with clean room operations, media fills, sterilization, depyrogenation, endotoxin reduction, and microbiological monitoring.
• Travel