Senior Process Engineer - Weekends

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.Our Promise: Caring, Sharing, GrowingWe will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.Job Description: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 multi-disciplinary teams. The process engineer will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. The individual will be responsible for refining department and site processes and provide leadership and guidance to others.General:Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainabilityOversee and assess existing processes and workflowsEstablish and track process metrics to monitor process stability and discover areas for improvementTechnical Transfer of new products from both internal and external clientsOwnership of product process from initial quote to product retirementEvaluate incoming processes for robustness, efficiency and fit within JHS-SpokanePerform 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 processesReview 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 impactImplement effective CAPAsResponsible for optimizing gross profit margin and minimizing deviation rateProvide necessary reviews for regulatory and client audits and provide responses to audit observationsIn-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.