Manufacturing Support Engineer

United Pharma; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

United Pharma in Madison, WI is seeking a Manufacturing Support Engineer to provide on-the-floor EFU technical support for all unit operations. You will respond to operator questions, troubleshoot EFU issues, and ensure safe, efficient, and uninterrupted manufacturing operations.

This is a full-time, on-site role focused on rapid problem-solving. As the SME for EFU, you will partner with Maintenance, Facilities, Automation, and Engineering to minimize downtime, drive reliability, and support GMP

Qualifications

• Excellent communication skills with operators and cross-functional teams.
• Ability to analyze technical data, identify root causes, and implement solutions.
• Experience troubleshooting manufacturing equipment, process systems, or production operations.
• Strong knowledge of GMP, deviation management, change control, and CAPA processes.

Responsibilities

• Provide daily on-the-floor technical support for manufacturing operations.
• Support setup, startup, operation, and shutdown of production equipment and processes.
• Serve as the first point of contact for equipment and technical issues during manufacturing activities.
• Monitor performance and identify issues before they impact production.
• Lead real-time troubleshooting of EFU issues to minimize downtime.
• Investigate problems and implement corrective actions with cross-functional teams.
• Assist with readiness activities to prepare equipment and systems for execution.
• Review EFU documentation and support deviations, investigations, and CAPAs.

Skills

Excellent communication

Problem solving

Analytical thinking

Urgent technical support

Education

Bachelor's degree in Engineering/related technical discipline

Job description

The Manufacturing Support Engineer serves as the primary equipment, facility, and utility (EFU) technical resource for manufacturing operations, providing real-time on-the-floor support for production activities. This role is responsible for supporting unit operation setup, responding to operator questions, troubleshooting EFU issues, and ensuring safe, efficient, and uninterrupted manufacturing operations. This is a full-time on-the-floor support position.

The position works directly with operators, manufacturing management, maintenance, quality, validation, MS&T, and engineering teams to resolve technical issues, minimize downtime, and maintain compliance with GMP requirements. The successful candidate will act as a Subject Matter Expert (SME) for manufacturing EFU, providing immediate support to production while driving operational reliability and continuous improvement.

Key Responsibilities

Manufacturing Floor Support

• Provide daily on-the-floor technical support for manufacturing operations across all assigned unit operations.
• Support setup, startup, operation, and shutdown of production equipment and manufacturing processes.
• Serve as the first point of contact for operators regarding equipment and technical issues during manufacturing activities.
• Monitor manufacturing performance and identify potential issues before they impact production.
• Actively participate in daily before-shift and after-shift hand-off reviews with MFG and outgoing/incoming Manufacturing Support Engineer.

Technical Troubleshooting

• Lead real-time troubleshooting EFU issues to minimize production downtime.
• Support process SMEs in real-time troubleshooting of process-related issues.
• Investigate mechanical, process, automation, and operational problems impacting manufacturing activities.
• Analyze process and equipment data to identify root causes and implement effective corrective actions.
• Partner with Maintenance, Facilities, Automation, and Engineering teams to resolve recurring equipment and operational issues.
• Provide technical assessments and recommendations to improve equipment reliability and operational performance

Equipment and Process Support

• Act as the SME for assigned manufacturing systems, single-use technologies, and unit operations.
• Assist with consumable and raw material integration to ensure compatibility with manufacturing processes and equipment.
• Evaluate equipment and process performance trends and recommend improvements to increase efficiency and reliability.
• Support manufacturing readiness activities to ensure production equipment and systems are prepared for execution.

Documentation and Compliance

• Review and support manufacturing EFU documentation including batch records, SOPs, work instructions, and technical reports.
• Provide technical input for deviations, investigations, change controls, CAPAs, and risk assessments.
• Support root cause analysis activities and assist in identifying sustainable corrective and preventive actions.
• Ensure technical documentation accurately reflects manufacturing practices and regulatory requirements.
• Support data gathering, analysis, and documentation associated with production events and investigations.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality Assurance, Quality Control, MS&T, Validation, Facilities, and Supply Chain to resolve production-related issues.
• Communicate technical findings, operational concerns, and recommended actions to stakeholders in a clear and timely manner.
• Participate in production meetings and provide technical updates related to ongoing manufacturing activities.
• Support successful execution of GMP manufacturing campaigns through proactive technical engagement.

Training and Knowledge Sharing

• Provide technical guidance and coaching to operators, manufacturing personnel, and other Engineering and support staff.
• Support training initiatives related to equipment operation, troubleshooting, and process execution.
• Share lessons learned and best practices to improve operational knowledge across manufacturing teams.
• Serve as a technical resource during EFU-related manufacturing investigations and operational reviews.

Required Qualifications

• Bachelor's degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline.
• 5+ years of experience supporting cell culture, purification, mRNA, or other biologics manufacturing processes.
• Demonstrated experience troubleshooting manufacturing equipment, process systems, or production operations.
• Strong understanding of GMP manufacturing practices, deviation management, change control, and CAPA processes.
• Ability to analyze technical data, identify root causes, and implement practical solutions.
• Excellent communication skills with the ability to work effectively with operators and cross-functional teams.
• Ability to work in a fast-paced production environment and provide urgent technical support when needed

Preferred Qualifications

• Knowledge of single-use manufacturing technologies and consumable lifecycle management.
• Experience with manufacturing automation systems and process control systems.
• Familiarity with risk assessments, investigation tools, and continuous improvement methodologies.
• Previous experience serving as a manufacturing, process, or equipment SME.
• Manufacturing Floor Presence
• Technical Troubleshooting Ownership, from Identification to Resolution and CAPA
• Equipment Reliability
• GMP Compliance
• Process Understanding
• Operational Excellence
• Cross-Functional Collaboration
• Problem Solving
• Communication and Coaching

This role is primarily focused on hands-on manufacturing support, unit operation setup, rapid troubleshooting, operator assistance, and minimizing production downtime through direct engagement on the manufacturing floor.