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 Responsibilities- Work 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 manufacturability
- Demonstrate technical experience and expertise to build customer confidence in WSS's ability to produce their product
- Work under the technical direction of Senior Development Engineers, the Product Development Engineering Manager, or other subject matter experts on complex, high-visibility problems
- Provide technical direction, guidance, and mentoring for Associate Development Engineers
- Define experimental designs for process development and optimization; define, justify, and acquire required laboratory equipment and instruments
- Provide engineering technical guidance to production teams to improve key commercial processes
- Define 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 data
- Collect and analyze experimental data using engineering principles and mathematical techniques, exercising independent judgment
- Define critical process parameters, operating ranges, and acceptance criteria supporting sterility assurance and process validation activities
- Support regulatory submissions and defend process-related information in customer filings, internal documents, and government audits
- Document process development activities in accordance with Good Documentation Practices (R&D notebooks, engineering studies, test runs, feasibility studies); author comprehensive product development plans
- Consult external academic and industrial resources, guidance documents, standards, and regulations as needed
- Create design concepts and basic CAD drawings/assemblies, isometrics, P&IDs, and shop drawings
- Troubleshoot technical issues related to sterile/sanitary processes, investigate problems, and support or execute corrective actions
- Act as technical subject matter expert on multi-disciplinary project teams; ensure key milestones are achieved and communicate risks to stakeholders
- Review test reports and certificates for compliance with specifications for raw materials, finished products, and vendor documentation
- Utilize Design of Experiments, Risk Assessments (e.g., FMEA), Quality by Design, and statistical tools to identify and solve problems early in the development process
- Maintain effectiveness of Quality System components relevant to the position; identify, evaluate, and communicate risk throughout the organization
QualificationsEducation:- Bachelor of Science in Chemistry, Pharmacy, Engineering, or a relevant discipline required
- Master of Science or PhD in Chemistry, Pharmacy, Engineering, or a relevant discipline desired
Experience:- Minimum of 5 years of relevant experience in pharmaceutical drug product process development, or a combination of lower experience with a strong academic background
- Experience in sterile processing or liquid drug formulation preferred
- Experience with large molecule and/or biologics products is beneficial
- Experience in personal care or food science industries may be considered relevant
Knowledge & Skills:- Strong knowledge of mathematics, mechanical aptitude, and statistical analysis for research and development; working knowledge of Quality by Design principles
- Strong problem-solving and analytical skills with a high level of attention to detail
- Excellent documentation and communication skills, both written and oral, at all levels of the organization
- Full 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 management
- Ability to work independently and/or in a team environment across multiple projects; flexible and adaptable to changing priorities
- Ability to perform timely risk assessments and act accordingly
- Familiarity with cGMP principles or the ability to quickly learn and apply them; commitment to safe work practices
- Demonstrated bias toward action, active listening, and a willingness to share skills and knowledge with others
Physical Requirements- Ability to work in pharmaceutical manufacturing and office environments
- Ability to stand for up to 8 hours per day on occasion
- May be required to work in environments requiring protective gear and awareness of personal and workplace safety
- Frequent sitting, standing, walking, climbing ladders/steps, reaching, stooping, kneeling, crouching, and bending
- Occasional lifting or moving of manufacturing equipment
- Capable of gown and respirator certification
Notice 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.
