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

Apply

Vacancy posted a month ago

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