Process Engineer, Sr.

Senior Process Engineer Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC, is a well‑established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life‑changing medicines worldwide. We are nationally recognized for producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Why Builders Choose Us Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide. Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well‑being shouldn’t have a waiting period. A career you can grow: Opportunities for growth, promotion, and annual raises; midpoint compensation reserved for high performance and longevity. A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands‑on contribution. A stable industry leader: Backed by Jubilant Pharma, we pair long‑term stability with forward‑looking innovation. Job Description 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. Troubleshoot, oversee and/or sample events within Manufacturing; occasional off‑shift at‑location support may be required. 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 sterile products, and ensure corrective action measures are implemented when required. Participate in or perform deviation investigation and evaluate 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 cGMPs, 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. Level Specific Expected to perform job functions autonomously and effectively. Expected to be an authority in pertinent scientific principles and applicable existing and new guidance. Expected to be an authority on technical aspects of site processes. Expected to provide leadership and guidance to others on these topics, and update and improve site practices and policies accordingly. Qualifications Bachelor’s of Arts or Science in Biology, Chemistry, Physics, or Engineering (required). 5-10 years of related pharmaceutical or FDA‑regulated industry experience. Supervisory or other leadership experience (required). Project management experience (required). Master’s Degree counts as two years of experience. Statistical analysis desired. Lean manufacturing principles desired. Microsoft Office experience (required). Extended periods of sitting or standing required. Ability to lift 40 lbs. unassisted (required). Location & Details Spokane, WA — On‑site, Full‑Time. Shift: Monday‑Friday, 5x8hr. Relocation available. Compensation & Benefits Hiring Wage: $98,700.00 – $157,900 annually, depending on experience. Opportunity for growth, promotion and annual raises. Benefits start on day one: 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. Equal Employment Opportunity 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 If you require assistance applying for a position, contact . We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society. #J-18808-Ljbffr