Senior Process Engineer - Weekdays

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 DescriptionThe 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.GeneralDesign, 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 ManufacturingAuthor validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable productDevelop and execute validation studies to test and qualify new and improved manufacturing processesTroubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off‑shift at‑location supportGenerate 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/warrantedParticipate 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 controlLevel SpecificExpected to perform job functions autonomously and effectivelyExpected to be an authority in pertinent scientific principles and applicable existing and new guidanceExpected to be an authority on technical aspects of site processesExpected to provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordinglyQualificationsA Bachelor's of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required5-10 years related Pharmaceutical experience or FDA regulated Industry Experience requiredSupervisory or other Leadership Experience requiredProject Management experience requiredMaster's Degree counts as 2 yrs experienceStatistical Analysis desiredLean Manufacturing Principles desiredMicrosoft Office experience requiredExtended periods of sitting or standing requiredAbility to lift 40 lbs. unassisted requiredShift4 days at 10 hours per day (Weekend Shift: Friday‑Monday or Thursday‑Sunday)5 days at 8 hours per day (Weekend Shift: Wednesday‑Sunday OR Thursday‑Monday OR Friday‑Tuesday)Compensation & BenefitsThis is an on‑site, full‑time position located in Spokane, WA.Hiring Wage: $98,700.00 – $157,900 annually depending on experience, with opportunity for growth, promotion and annual raisesEach shift has defined core coverage: Weekday Shift (Shift 1 - no shift differential) - Core days are Monday through Thursday; Weekend Shift (weekend days - shift diff 7.5%) - Core days are Friday through SundayMedical, Dental, Vision, Flexible Spending and Health Savings AccountsLife, AD&D, Short and Long Term Disability401(k) with company matchGenerous paid time off planEmployee Assistance ProgramUnlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If you require assistance applying for a position, please contact our HR Department at: JHS‑TalentAcquisition@jubl.com#J-18808-Ljbffr