Process Engineer - Engineering
Catalent
Catalent's Madison biologics manufacturing facility seeks a Process Engineer to optimize biologics development and manufacturing operations. The role involves process improvement, technical troubleshooting, risk assessment, and cross-functional project leadership in a GMP environment utilizing single-use systems and proprietary cell line technologies.
Responsibilities
- Evaluate processes and identify improvements for efficiency, cost savings, and consistency gains
- Lead technical support for risk assessments, gap analysis, deviations, root-cause analysis, and corrective actions
- Support User Required Specifications drafting and participate in Factory/Site Acceptance Testing and Qualification/Validation activities
- Oversee manufacturing technical support including change management, troubleshooting, and site strategy project oversight
- Track, trend, and analyze data for compliance, product quality, continuous improvement, and investigations
Requirements
- Bachelor's degree in engineering or related scientific field plus 3+ years cGMP facilities/automation experience, or Master's degree plus 1+ year experience
- Experience in biopharmaceutical manufacturing or cGMP environments
- Strong data interpretation and trend analysis capabilities
- Proficiency with investigation, deviation, and change control documentation
- Ability to lead cross-department facility improvement projects
- Technical writing and SOP development experience
- Capability to introduce new technology and drive process improvements
Vacancy posted 8 days ago
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