Process Engineer

Woodstock Sterile Solutions; Illinois; On-site; USD 85,000 - 110,000; Full time

Job summary

Woodstock Sterile Solutions in Woodstock, Illinois, is seeking a Process Engineer to partner with Operations, Quality, Engineering, and Product Development to identify and implement robust processes that improve efficiency and reduce costs across BFS manufacturing.

The role encompasses project leadership, process optimization, equipment design input, investigations of deviations, and maintaining quality systems. BS in a relevant field and 1–6 years in regulated industries are expected.

Qualifications

• BS degree in engineering, chemistry, pharmacy, or related discipline.
• 1–6 years of experience in pharma, medical device, food, or FDA-regulated industry.
• Six Sigma Green Belt/Black Belt or LEAN Master certification is a plus.

Responsibilities

• Lead projects from approval to completion within time and budget.
• Collaborate with cross-functional teams to identify and implement process improvements.
• Assist in design of process equipment and support commissioning.
• Participate in investigations to identify root causes for OOS and implement CAPAs.
• Document commissioning, qualification, and change history; conduct engineering studies.
• Evaluate and improve process controls; update CQAs and CPPs.
• Maintain Quality System components and manage risk.
• Perform other duties as assigned.

Skills

Mechanical aptitude

Problem solving

Analytical skills

Experience with cGMP

Microsoft Excel

Microsoft Word

PowerPoint

Visio

English communication

Education

BS degree in Engineering, Chemistry, Pharmacy, or related field

Six Sigma Green Belt/Black Belt or LEAN Master certification

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Access

Visio

Job description

Job Description

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 Process Engineer is responsible for interfacing with Operations, Quality, Engineering, and Product Development to identify and implement robust solutions that realize efficiencies, enhance capability, and reduce overall execution costs across our BFS manufacturing operations.

Key Responsibilities

• Lead approved projects and drive them to completion while maintaining project timelines and budget objectives for small to medium projects.
• Collaborate with cross-functional teams to identify, evaluate, develop, and implement process improvements that drive operational excellence and process reliability, based on supporting data, technical knowledge, engineering principles, and current Good Manufacturing Practices (cGMPs).
• Collaborate on the design of process equipment; assist vendors during installation and commissioning of new process equipment; review engineering specifications across pneumatics, electronics, controls, and other integration facets.
• Participate in investigations to identify root causes for process discrepancies or out-of-specification (OOS) results, and implement effective corrective and/or preventive actions (CAPAs) to ensure product quality and customer safety.
• Utilize good engineering practices and change management systems to document equipment commissioning, qualification, and change history; author and execute engineering studies using experimental design and statistical analysis principles.
• Evaluate and improve process controls to ensure reliable, repeatable manufacturing by updating critical instrumentation systems, process drawings, manufacturing instructions, and procedures; understand the control strategy between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
• Demonstrate proficiency in the Blow-Fill-Seal manufacturing process, including compounding, filling, and packaging, with strong aseptic technique and sterility assurance practices.
• Maintain effectiveness of Quality System components relevant to this position; identify, evaluate, and manage risk to ensure product quality, communicating risk policies and processes throughout the organization.
• Perform other duties as assigned.

Qualifications

Education: Bachelor of Science degree in Engineering, Chemistry, Pharmacy, or other relevant discipline required.

Experience: 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.

Knowledge & Skills:

• Strong mechanical aptitude with excellent problem-solving and analytical skills
• Experience with cGMP (current Good Manufacturing Practices)
• Full complement of business computer literacy, including Microsoft Excel, Word, PowerPoint, Access, and Visio
• Ability to work independently across multiple concurrent projects
• Completion of OSHA 10-hour training with active knowledge/application of course content
• Demonstrated ability to read, write, and speak clear English

Physical Requirements

• Manufacturing and office environments; sitting, standing, and working at a computer up to 8 hours per day
• Frequent sitting, standing, walking, reading of written documents, and use of a computer monitor screen; talking, writing, and listening
• Occasional climbing ladders/steps, walking on inclines and uneven terrain, reaching, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, and grasping
• Occasional lifting and/or moving up to 30 pounds