Position SummaryThe 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.
The 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.
Key Responsibilities- Lead formulation development, feasibility, scale-up, tech transfer, and commercialization activities for BFS products.
- Provide technical support to Business Development to demonstrate WSS capabilities and support new business opportunities.
- Define experimental designs, required laboratory equipment, process parameters, operational ranges, and acceptance criteria.
- Provide technical direction, guidance, and mentoring to Associate Development Engineers and Development Engineers.
- Specify, source, install, and commission process equipment and hardware, including sanitary vessels, tubing, valves, instruments, filter housings, steam traps, and disposable components.
- Develop scalable, robust processes that meet product specifications and support customers in establishing specifications based on feasibility and process capability results.
- Collect, reduce, and analyze experimental data using engineering principles, mathematical techniques, and statistical tools.
- Define critical process parameters and operational ranges supporting sterility assurance and process validation activities.
- Support regulatory submissions, customer filings, internal documentation, and government audits by defending process-related information.
- Document process development in R&D notebooks, engineering studies, test runs, feasibility studies, and comprehensive product development plans in accordance with Good Documentation Practices.
- Create design concepts, production-level CAD drawings and assemblies, isometric drawings, P&IDs, and shop drawings.
- Troubleshoot sterile and sanitary process issues, investigate problems, support corrective actions, and prepare technical reports.
- Provide technical guidance for commercial product sterilization, sanitary piping, and sterile product transfer processes.
- Act as a technical subject matter expert on multidisciplinary project teams and ensure technical milestones are achieved.
- Review test reports and certificates related to raw materials, finished products, pressure tests, material testing, welds, electropolish, passivation, and related specifications.
- Apply Design of Experiments, FMEA, Quality by Design, risk assessments, and statistical tools to identify and resolve problems early.
- Sponsor or support change controls, deviations, CAPAs, and other Quality System activities as required.
- Maintain compliance with Health, Safety, and Environmental responsibilities and perform other duties as assigned.
QualificationsEducation- Bachelor of Science degree in Chemistry, Pharmacy, Engineering, or a relevant discipline required.
- Master of Science or Ph.D. in Chemistry, Pharmacy, Engineering, or a relevant discipline preferred.
Experience- Seven or more years of relevant experience in pharmaceutical drug product process development, or an equivalent combination of experience and strong academic preparation.
- Experience in sterile processing or liquid drug formulation preferred.
- Experience with large molecules and/or biologics beneficial.
- Lean and/or Six Sigma experience beneficial.
- Experience in personal care or food science may be considered relevant.
Knowledge & Skills- Strong knowledge of mathematics, mechanical aptitude, statistical analysis, and Quality by Design principles.
- Excellent problem-solving, analytical, documentation, technical writing, and communication skills.
- Ability to work independently and collaboratively on multiple projects while adapting to changing priorities.
- Ability to lead project teams, influence decisions, perform timely risk assessments, and foster teamwork.
- Advanced ability to lead and author investigations and CAPAs.
- Proficiency with word processing, spreadsheets, databases, design software, and related business applications.
- Knowledge of cGMP principles and safe work practices, or the ability to learn and apply them quickly.
- Ability to read, write, and speak clear English.
Physical Requirements & Work Environment- Work in both pharmaceutical manufacturing and office environments.
- Ability to stand for up to 12 hours per day on occasion and work in areas requiring protective gear.
- Frequent sitting, standing, walking, climbing ladders or steps, reaching, stooping, kneeling, crouching, bending, grasping, talking, and listening.
- Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds.
- Capable of gown and respirator certification.
- Fast-paced, performance-driven, customer-focused, collaborative, and inclusive work environment.
