{"id":2102862,"url":"https://alion.io/job/woodstock-sterile-solutions-sr-development-engineer","title":"Sr. Development Engineer","company":{"id":3868298,"name":"Woodstock Sterile Solutions","domain":"woodstocksterilesolutions.com","url":"https://alion.io/company/woodstocksterilesolutions","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Woodstock, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":110000,"max":130000,"currency":"USD","period":"year","gross":null,"usd_annual":130000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"closed","first_seen_at":"2026-09-09T18:18:00Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-10-31T17:59:52Z","board_verified":false,"closed_at":"2026-10-31T17:59:52Z","days_open":51,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":51},"description":"About Woodstock Sterile Solutions\nWoodstock Sterile Solutions is a leading North American blow-fill-seal (BFS) sterile contract development and manufacturing organization. With more than 50 years of BFS expertise, advanced aseptic manufacturing capabilities, and a commitment to innovation, we help pharmaceutical and biotechnology partners bring critical products from development through commercialization.\nPosition Summary\nThe Senior Development Engineer leads pre-development through scale-up and commercialization of formulations and processes for new customers and products while driving continuous improvement of existing formulations and processes. This role partners directly with customer scientists, development and process engineers, Business Development, Manufacturing, Quality, and other cross-functional teams to translate product concepts into robust, scalable BFS processes.\nThe Senior Development Engineer serves as a technical subject matter expert, provides mentorship to Development Engineers, supports customer and regulatory needs, and applies Design of Experiments, Quality by Design, risk assessment, statistical tools, and engineering principles to deliver technically sound solutions.\nKey Responsibilities\nLead formulation development, feasibility, scale-up, tech transfer, and commercialization activities for BFS products.\n\nProvide technical support to Business Development to demonstrate WSS capabilities and support new business opportunities.\n\nDefine experimental designs, required laboratory equipment, process parameters, operational ranges, and acceptance criteria.\n\nProvide technical direction, guidance, and mentoring to Associate Development Engineers and Development Engineers.\n\nSpecify, source, install, and commission process equipment and hardware, including sanitary vessels, tubing, valves, instruments, filter housings, steam traps, and disposable components.\n\nDevelop scalable, robust processes that meet product specifications and support customers in establishing specifications based on feasibility and process capability results.\n\nCollect, reduce, and analyze experimental data using engineering principles, mathematical techniques, and statistical tools.\n\nDefine critical process parameters and operational ranges supporting sterility assurance and process validation activities.\n\nSupport regulatory submissions, customer filings, internal documentation, and government audits by defending process-related information.\n\nDocument process development in R&D notebooks, engineering studies, test runs, feasibility studies, and comprehensive product development plans in accordance with Good Documentation Practices.\n\nCreate design concepts, production-level CAD drawings and assemblies, isometric drawings, P&IDs, and shop drawings.\n\nTroubleshoot sterile and sanitary process issues, investigate problems, support corrective actions, and prepare technical reports.\n\nProvide technical guidance for commercial product sterilization, sanitary piping, and sterile product transfer processes.\n\nAct as a technical subject matter expert on multidisciplinary project teams and ensure technical milestones are achieved.\n\nReview test reports and certificates related to raw materials, finished products, pressure tests, material testing, welds, electropolish, passivation, and related specifications.\n\nApply Design of Experiments, FMEA, Quality by Design, risk assessments, and statistical tools to identify and resolve problems early.\n\nSponsor or support change controls, deviations, CAPAs, and other Quality System activities as required.\n\nMaintain compliance with Health, Safety, and Environmental responsibilities and perform other duties as assigned.\n\nQualifications\nEducation\nBachelor of Science degree in Chemistry, Pharmacy, Engineering, or a relevant discipline required.\n\nMaster of Science or Ph.D. in Chemistry, Pharmacy, Engineering, or a relevant discipline preferred.\n\nExperience\nSeven or more years of relevant experience in pharmaceutical drug product process development, or an equivalent combination of experience and strong academic preparation.\n\nExperience in sterile processing or liquid drug formulation preferred.\n\nExperience with large molecules and/or biologics beneficial.\n\nLean and/or Six Sigma experience beneficial.\n\nExperience in personal care or food science may be considered relevant.\n\nKnowledge & Skills\nStrong knowledge of mathematics, mechanical aptitude, statistical analysis, and Quality by Design principles.\n\nExcellent problem-solving, analytical, documentation, technical writing, and communication skills.\n\nAbility to work independently and collaboratively on multiple projects while adapting to changing priorities.\n\nAbility to lead project teams, influence decisions, perform timely risk assessments, and foster teamwork.\n\nAdvanced ability to lead and author investigations and CAPAs.\n\nProficiency with word processing, spreadsheets, databases, design software, and related business applications.\n\nKnowledge of cGMP principles and safe work practices, or the ability to learn and apply them quickly.\n\nAbility to read, write, and speak clear English.\n\nPhysical Requirements & Work Environment\nWork in both pharmaceutical manufacturing and office environments.\n\nAbility to stand for up to 12 hours per day on occasion and work in areas requiring protective gear.\n\nFrequent sitting, standing, walking, climbing ladders or steps, reaching, stooping, kneeling, crouching, bending, grasping, talking, and listening.\n\nFrequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds.\n\nCapable of gown and respirator certification.\n\nFast-paced, performance-driven, customer-focused, collaborative, and inclusive work environment.\n\nNotice 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. 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