Manufacturing Engineer

United Pharma; Indiana; On-site; USD 75,000 - 110,000; Full time

Job summary

United Pharma in Indiana is seeking a Manufacturing Engineer to support manufacturing operations, quality systems, equipment qualification, and process validation in a regulated environment.

You will manage QMS documentation, ECOs, change controls, and technical writing; provide hands-on floor support and collaborate with maintenance and vendors to resolve issues.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 3–5 years of experience in manufacturing engineering, quality systems, validation, or process engineering.
• Hands-on experience with QMS documentation, ECOs, change control, and technical writing.
• Knowledge of equipment qualification, process validation, and regulated manufacturing environments.
• Strong troubleshooting, communication, organizational, and project management skills.

Responsibilities

• Manage QMS documentation, ECOs, change controls, SOPs, and work instructions.
• Develop and maintain technical documentation, process narratives, and installation qualification (IQ) protocols.
• Support equipment qualification, process validation, non-product software validation, and temperature mapping activities.
• Maintain controlled documents and change records using Windchill or similar PLM systems.
• Provide hands-on manufacturing floor support, troubleshoot equipment and process issues, and coordinate resolutions with maintenance teams and vendors.
• Support equipment calibration, preventive maintenance, packaging operations, material setup, and master data updates.

Skills

QMS documentation

ECOs

Change control

Technical writing

Troubleshooting

Communication

Project management

Manufacturing engineering

Education

Bachelor's degree in Engineering, Science, or related field

Tools

Windchill PLM

Job description

We are seeking a Manufacturing Engineer to support manufacturing operations, quality systems, equipment qualification, and process validation activities in a regulated manufacturing environment. The ideal candidate will have experience managing QMS documentation, engineering change controls, and technical documentation while providing hands‑on support for manufacturing equipment and operational processes.

Key Responsibilities & Requirements

• Manage QMS documentation, engineering change orders (ECOs), change controls, SOPs, and work instructions.
• Develop and maintain technical documentation, process narratives, and installation qualification (IQ) protocols.
• Support equipment qualification, process validation, non-product software validation, and temperature mapping activities.
• Maintain controlled documents and change records using Windchill or similar PLM systems.
• Provide hands‑on manufacturing floor support, troubleshoot equipment and process issues, and coordinate resolutions with maintenance teams and vendors.
• Support equipment calibration, preventive maintenance, packaging operations, material setup, and master data updates.

Required Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 3-5 years of experience in manufacturing engineering, quality systems, validation, or process engineering.
• Hands‑on experience with QMS documentation, ECOs, change control, and technical writing.
• Knowledge of equipment qualification, process validation, and regulated manufacturing environments.
• Strong troubleshooting, communication, organizational, and project management skills.