Process Engineer, Sr

About the Company

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next

As Spokane’s Largest Manufacturing Company, Jubilant Hollister Stier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life‑changing medicines around the world.

We are nationally recognized for our expertise in 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.

Jubilant Hollister Stier is proudly part of the global Jubilant Pharma family.

• 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:
  We provide opportunities for growth, promotion, and annual raises, with 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.

The Senior Process Engineer provides expertise primarily in the areas of pharmaceutical process engineering and technical transfer. This position will manage large‑scale projects and multidisciplinary teams, providing technical direction for complex projects and exhibiting superior communication skills with all levels of employees. The individual will be responsible for refining department and site processes and 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 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 or 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.

• 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, as well as update and improve…