Process Support Engineer III

Location: Lake County IL (Onsite)
Duration: 12 Months (Contract)
Work Schedule: Monday Friday standard business hours

We are seeking an experienced Process Support Engineer III to provide technical support and drive process improvements in a pharmaceutical manufacturing environment. This role focuses on sterile drug product manufacturing process validation and continuous improvement initiatives while ensuring compliance with GMP and regulatory standards.

• Lead process improvement initiatives to enhance yield quality throughput and cost efficiency
• Analyze manufacturing data using statistical process control (SPC) and develop action plans to improve process robustness
• Provide technical support to resolve shop floor manufacturing issues
• Lead deviation investigations using structured problem-solving methodologies and identify root causes
• Assess impact of deviations on product quality yield and regulatory compliance
• Collaborate with cross-functional teams to implement continuous improvement and site initiatives
• Manage small to mid-size projects including planning coordination tracking and reporting
• Lead and support process validation activities for process changes new materials and new technologies
• Assist in execution of validation demonstration and experimental batches
• Maintain and update process documentation in compliance with GMP requirements
• Provide technical support during regulatory audits and inspections
• Ensure adherence to Environmental Health & Safety (EHS) standards

• Bachelors Masters or PhD in Engineering (Chemical Mechanical Biochemical) or Chemistry
• 5 7 years of experience in pharmaceutical manufacturing or process engineering
• Strong experience in sterile drug product manufacturing
• Hands-on experience with GMP and process validation
• Experience working with Contract Manufacturing Organizations (CMOs)
• Exposure to technical transfer activities
• Strong analytical and problem-solving skills including experience with SPC tools
• Excellent written and verbal communication skills
• Ability to work in a fast-paced cross-functional environment
• Willingness to travel (domestic and/or international)

• Technical Transfer
• Sterile Manufacturing
• Process Validation (GMP)
• Deviation Investigation & CAPA
• Statistical Data Analysis (SPC)
• Continuous Improvement