Senior Development Engineer - BFS Process Innovator

ADP, Inc.; Woodstock (IL); On-site; USD 110,000 - 130,000; Full time

Job summary

Woodstock Sterile Solutions in Woodstock, IL is seeking a Senior Development Engineer to lead pre-development through scale-up and commercialization of BFS formulations. You will collaborate 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 role requires DoE, QbD, risk assessment, and statistical tools to deliver technically sound

Qualifications

• Bachelor of Science degree in Chemistry, Pharmacy, Engineering, or a relevant discipline.
• MS or PhD in Chemistry, Pharmacy, Engineering preferred.
• 7+ years in pharmaceutical drug product process development.
• Experience in sterile processing or liquid drug formulation beneficial.

Responsibilities

• Lead formulation development, feasibility, scale-up, tech transfer, and commercialization.
• Provide technical support to Business Development to demonstrate WSS capabilities.
• 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.

Skills

Problem-solving

Analytical thinking

Communication skills

Team leadership

Independent work

Education

Bachelor's degree in Chemistry, Pharmacy, Engineering, or relevant

Master's degree or Ph.D. in Chemistry, Pharmacy, Engineering, or relevant (preferred)

Job description

Woodstock Sterile Solutions in Woodstock, IL is seeking a Senior Development Engineer to lead pre-development through scale-up and commercialization of BFS formulations. You will collaborate 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 role requires DoE, QbD, risk assessment, and statistical tools to deliver technically sound