Process Engineer, Sr.

Job Description The Senior Process Engineer provides expertise primarily in pharmaceutical process engineering and technical transfer. This position manages large‑scale projects and multi‑disciplinary teams, offers technical direction for complex initiatives, and demonstrates superior communication skills at all levels. The engineer refines department and site processes, provides leadership, and guides others. Responsibilities 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 identify improvement opportunities. Perform technical transfer of new products from internal and external clients. Own the product process from initial quote through retirement. Evaluate incoming processes for robustness, efficiency, and fit within JHS‑Spokane. Define CPPs and CQAs to enable strong execution upon transfer to manufacturing. Author validation study documents that demonstrate manufacturing processes consistently meet product quality. Develop and execute validation studies to qualify new and improved manufacturing processes. Provide occasional off‑shift onsite support for troubleshooting, oversight, or sampling of events within manufacturing. Generate reports summarizing study results and use data to qualify site processes. Review data summaries from other departments, assess trends or conditions that may affect sterile product quality, and ensure corrective actions when necessary. Participate or perform deviation investigations and evaluate impact. Implement effective CAPAs. Optimize gross profit margin and minimize deviation rate. Provide necessary reviews for regulatory and client audits and respond to audit observations. Maintain in‑depth understanding of cGMPs, European regulatory requirements, USP chapters, and scientific principles related to clean‑room operations, media fills, sterilization, depyrogenation, endotoxin reduction, and microbiological monitoring. Travel Level Specific Performs job functions autonomously and effectively. Serves as authority on pertinent scientific principles and guidance. Possesses deep knowledge of technical aspects of site processes. Provides leadership and guidance on these topics, and updates site practices and policies accordingly. Qualifications Bachelor’s in Biology, Chemistry, Physics, or Engineering required. 5‑10 years of pharmaceutical or FDA‑regulated industry experience required. Supervisory or leadership experience required. Project management experience required. Master’s degree counts as 2 years of experience. Statistical analysis desired. Lean manufacturing principles desired. Microsoft Office experience required. Ability to sit or stand for extended periods. Ability to lift 40 lbs. unassisted required. Location Spokane, WA – On‑site, full‑time. Shift Monday‑Friday, 5 × 8 hr. Relocation Available Yes. Compensation & Benefits Hiring wage: $98,700.00 – $157,900 annually, depending on experience, with opportunities for growth, promotion, and annual raises. Benefits commence on day one and include: Medical, Dental & Vision coverage Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) Life & AD&D insurance Short‑Term & Long‑Term Disability insurance Employee Assistance Program EEO Statement Jubilant HollisterStier is an EEO/AA employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Contact For assistance applying, contact View email address on click.appcast.io . #J-18808-Ljbffr Jubilant HollisterStier LLC