Development Engineer

Woodstock Sterile SolutionsWoodstock Sterile Solutions is the leading North American blow-fill-seal (BFS) sterile contract development and manufacturing organization (CDMO). From our 430,000 sq. ft. advanced aseptic manufacturing facility in Woodstock, Illinois, we leverage 50+ years of BFS technology leadership and our patented cold BFS process to serve clients from clinical development through commercial scale. We are committed to Proven Excellence. Trusted Solutions.Position OverviewThe Development Engineer is responsible for pre-development through scale-up and commercialization of formulations and processes for new customers and products. This role partners directly with customer scientists and engineers to bring innovative formulations into our patented blow-fill-seal (BFS) packaging platform, from early feasibility through full commercial-scale production.Key ResponsibilitiesWork directly with customer scientists, development, and process engineers on formulation development, feasibility, scale-up, and commercialization into blow-fill-seal (BFS) packaging, including physicochemical attributes, consistency, and manufacturabilityDemonstrate technical experience and expertise to build customer confidence in WSS's ability to produce their productWork under the technical direction of Senior Development Engineers, the Product Development Engineering Manager, or other subject matter experts on complex, high-visibility problemsProvide technical direction, guidance, and mentoring for Associate Development EngineersDefine experimental designs for process development and optimization; define, justify, and acquire required laboratory equipment and instrumentsProvide engineering technical guidance to production teams to improve key commercial processesDefine user requirements for new equipment and hardware (stainless steel vessels, tubing, fittings, sanitary valves, filter housings, steam traps, instruments, gauges, disposable components)Develop scalable, robust processes that meet product specifications; assist customers in developing specifications based on feasibility and process capability dataCollect and analyze experimental data using engineering principles and mathematical techniques, exercising independent judgmentDefine critical process parameters, operating ranges, and acceptance criteria supporting sterility assurance and process validation activitiesSupport regulatory submissions and defend process-related information in customer filings, internal documents, and government auditsDocument process development activities in accordance with Good Documentation Practices (R&D notebooks, engineering studies, test runs, feasibility studies); author comprehensive product development plansConsult external academic and industrial resources, guidance documents, standards, and regulations as neededCreate design concepts and basic CAD drawings/assemblies, isometrics, P&IDs, and shop drawingsTroubleshoot technical issues related to sterile/sanitary processes, investigate problems, and support or execute corrective actionsAct as technical subject matter expert on multi-disciplinary project teams; ensure key milestones are achieved and communicate risks to stakeholdersReview test reports and certificates for compliance with specifications for raw materials, finished products, and vendor documentationUtilize Design of Experiments, Risk Assessments (e.g., FMEA), Quality by Design, and statistical tools to identify and solve problems early in the development processMaintain effectiveness of Quality System components relevant to the position; identify, evaluate, and communicate risk throughout the organizationQualificationsEducation:Bachelor of Science in Chemistry, Pharmacy, Engineering, or a relevant discipline requiredMaster of Science or PhD in Chemistry, Pharmacy, Engineering, or a relevant discipline desiredExperience:Minimum of 5 years of relevant experience in pharmaceutical drug product process development, or a combination of lower experience with a strong academic backgroundExperience in sterile processing or liquid drug formulation preferredExperience with large molecule and/or biologics products is beneficialExperience in personal care or food science industries may be considered relevantKnowledge & Skills:Strong knowledge of mathematics, mechanical aptitude, and statistical analysis for research and development; working knowledge of Quality by Design principlesStrong problem-solving and analytical skills with a high level of attention to detailExcellent documentation and communication skills, both written and oral, at all levels of the organizationFull complement of business computer literacy skills (word processing, spreadsheets, design software, database software, etc.)Ability to interface with technical and non-technical customer representatives, outside suppliers, and WSS managementAbility to work independently and/or in a team environment across multiple projects; flexible and adaptable to changing prioritiesAbility to perform timely risk assessments and act accordinglyFamiliarity with cGMP principles or the ability to quickly learn and apply them; commitment to safe work practicesDemonstrated bias toward action, active listening, and a willingness to share skills and knowledge with othersPhysical RequirementsAbility to work in pharmaceutical manufacturing and office environmentsAbility to stand for up to 8 hours per day on occasionMay be required to work in environments requiring protective gear and awareness of personal and workplace safetyFrequent sitting, standing, walking, climbing ladders/steps, reaching, stooping, kneeling, crouching, and bendingOccasional lifting or moving of manufacturing equipmentCapable of gown and respirator certificationNotice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.