Aseptic Process Engineer for BFS Manufacturing

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 80,000 - 105,000; Full time

Job summary

Woodstock Sterile Solutions, a leading BFS CDMO in Woodstock, IL, seeks a Process Engineer to drive cross-functional process improvements and implement cost-saving manufacturing solutions. You will work with Operations, Quality, Engineering, and Product Development to optimize cGMP-compliant processes.

Responsibilities include leading projects, collaborating on device and equipment design, investigating root causes, and executing CAPAs to ensure product quality and safety.

Qualifications

• Bachelor of Science degree in Engineering, Chemistry, Pharmacy, or other relevant discipline required.
• 1–6 years of relevant experience in the pharmaceutical, medical device, food, or other FDA-regulated industry required.
• Six Sigma (Green Belt/Black Belt) or LEAN Master certification a plus.
• Strong mechanical aptitude with problem-solving and analytical skills.
• Experience with cGMP (current Good Manufacturing Practices).
• Proficient in Microsoft Excel, Word, PowerPoint, Access, and Visio.
• Ability to work independently across multiple concurrent projects.
• Completion of OSHA 10-hour training with active knowledge of content.
• Demonstrated ability to read, write, and speak clear English.

Responsibilities

• Lead approved projects and drive them to completion while maintaining timelines and budget objectives for small to medium projects.
• Collaborate with cross-functional teams to identify, evaluate, develop, and implement process improvements for operational excellence and reliability.
• Assist in design of process equipment and support installation and commissioning activities across pneumatics, electronics, controls, and integration facets.
• Investigate root causes for process discrepancies and implement CAPAs to ensure product quality and safety.
• Document equipment commissioning, qualification, and change history; perform engineering studies using experimental design and statistics.
• Improve process controls by updating instrumentation, drawings, and procedures; align CQAs with CPPs.
• Demonstrate expertise in Blow-Fill-Seal manufacturing, including aseptic technique and sterility practices.
• Maintain Quality System components relevant to position and communicate risk policies.
• Perform other duties as assigned.

Skills

Mechanical aptitude

Problem-solving

Analytical thinking

Independent work

Education

Bachelor of Science in engineering or related field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Microsoft Access

Visio

Job description

Woodstock Sterile Solutions, a leading BFS CDMO in Woodstock, IL, seeks a Process Engineer to drive cross-functional process improvements and implement cost-saving manufacturing solutions. You will work with Operations, Quality, Engineering, and Product Development to optimize cGMP-compliant processes.

Responsibilities include leading projects, collaborating on device and equipment design, investigating root causes, and executing CAPAs to ensure product quality and safety.