Senior Process Engineer

The Senior Process Engineer will ensure compliant, efficient, and safe transfer of new products, implementing manufacturing processes from concept to launch, including scaling up and aseptic process simulation.

Requirements

• Develop and author protocols to ensure compliance with FDA and cGMP requirements
• Monitor and analyze manufacturing data to support the full process lifecycle
• Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules
• Provide real-time troubleshooting for complex manufacturing equipment failures and process deviations
• Lead personnel training, develop manufacturing instructions, and support the start-up of new processes and equipment
• Collaborate with vendors and suppliers to define system requirements and validate functional specifications
• Develop and revise SOPs, ensuring alignment with regulatory and operational requirements
• Lead and manage change controls and conduct impact assessments to support compliant process modifications
• Support and lead investigations to determine root causes, perform data analysis, and drive effective CAPA implementation
• Verify and develop P&ID, engineering layout, engineering drawings and engineering documents
• Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, and communicating across teams at all levels

Benefits

• Generous Paid Time Off
• 401k Matching
• Health Insurance
• Dental Insurance
• Vision Insurance
• Disability Insurance
• Life Insurance
• Retirement Plan
• Health Savings Account (HSA)