Process Engineer III

JOB DESCRIPTION

Join a Leader in Pharmaceutical Manufacturing — And Build What's Next As 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 lifechanging 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 HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. For the Builders, Innovators, and Doers — This Is Your Place If you are someone who thrives on solving complex problems, improving systems, and building real solutions , you'll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally.

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:

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. If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here.

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 (