BFS Sterile Process 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

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.