Development Engineer

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 85,000 - 99,000; Full time

Job summary

Woodstock Sterile Solutions seeks a Development Engineer to take formulations from pre-development through scale-up for BFS packaging. You will partner with customer scientists and engineers to bring innovative formulations into our BFS platform, from feasibility to commercial-scale production.

The role requires strong math, design of experiments, and problem-solving skills, with experience in sterile processes and cGMP familiarity. Excellent communication and teamwork are essential.

Qualifications

• Bachelor’s degree in a relevant field is required.
• Minimum of 5 years in pharmaceutical drug product process development.
• Experience in sterile processing or liquid drug formulation preferred.
• Experience with large molecule and/or biologics products is beneficial.
• Knowledge of Quality by Design and statistical analysis is essential.
• Ability to work independently and in a team; strong communication.

Responsibilities

• Develop formulations and processes for BFS packaging and scale-up.
• Collaborate with customer scientists and engineers on feasibility and commercialization.
• Define experimental designs and acquire required lab equipment.
• Provide engineering guidance to production teams to improve processes.
• Develop scalable, robust processes meeting product specifications.
• Collect and analyze experimental data using engineering principles.
• Support regulatory submissions and audits with documentation.
• Mentor Associate Development Engineers and cross-functional teams.

Skills

Mathematics

Mechanical aptitude

Statistical analysis

Quality by Design

Problem-solving

Documentation

Communication skills

Team collaboration

cGMP familiarity

Continuous learning

Education

Bachelor of Science in Chemistry, Pharmacy, Engineering

Master of Science or PhD in Chemistry, Pharmacy, Engineering

Tools

CAD

P&IDs

Isometrics

Design software

Database software

Job description

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Full Time Woodstock, IL, US

23 days ago Requisition ID: 1312

Salary Range: $85,000.00 To $99,000.00 Annually

Woodstock 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 Overview

The 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

Qualifications

Education:

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