GMP Biotech Manufacturing Specialist

United Pharma; Madison (WI); On-site; USD 95,000 - 150,000; Full time

Job summary

United Pharma is seeking a skilled Manufacturing Engineer to drive cGMP production, process transfer, and continuous improvement in Madison, WI. You will collaborate with Process Execution and Compliance teams to ensure batch records, SOPs, and technical documentation meet regulatory standards.

The role requires strong problem-solving, data analysis, and cross-functional communication to support late-stage and commercial programs while advancing manufacturing efficiency and regulatory readiness.

Qualifications

• STEM degree with relevant experience in GMP manufacturing environments.
• Experience drafting SOPs, batch records, and reports.
• Knowledge of process transfer, CAPA, change controls, and deviations.

Responsibilities

• Lead rapid response troubleshooting for manufacturing processes.
• Collaborate across departments to transfer and maintain processes.
• Author batch documentation and provide technical oversight.
• Identify process improvements to boost efficiency and quality.
• Support CAPA, deviations, and change controls with root-cause analysis.

Skills

Troubleshooting

Data analysis

Documentation

SOP writing

Education

Associate's degree in STEM

Bachelor's degree in STEM

Master’s degree in STEM

Tools

TrackWise

ComplianceWire

Unicorn

Job description

United Pharma is seeking a skilled Manufacturing Engineer to drive cGMP production, process transfer, and continuous improvement in Madison, WI. You will collaborate with Process Execution and Compliance teams to ensure batch records, SOPs, and technical documentation meet regulatory standards.

The role requires strong problem-solving, data analysis, and cross-functional communication to support late-stage and commercial programs while advancing manufacturing efficiency and regulatory readiness.