Process Engineer

3 days ago

Madison WI USA, United States Catalent Inc Full time
Job Title: Process Engineer

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.

The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market-leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.

Leveraging our growing differentiated technology portfolio, world-class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Role:

Evaluate existing processes and identify process or equipment improvements to advance efficiency, cost savings, time savings, consistency, and competitiveness within the market.

Support the building of business case(s) for process improvement projects.

Author and review documents including bill of materials, process descriptions, project reports, engineering specifications, and summary reports.

Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.

Support drafting and development of User Required Specifications, support and attend Factory Acceptance Testing, Site Acceptance Testing, Qualification/Validation testing for existing and new technologies.

Lead site strategy projects with dedicated cross-department resources with Site Leadership (SLT) visibility through implementation.

Oversee technical support of Manufacturing, including change management (consumable lifecycle integration with site equipment, raw materials), SME troubleshooting, and leading or providing oversight on site strategy projects.

Work alongside a group of engineers, scientists, and other colleagues to oversee the process engineering function associated with mammalian biologic processes, mRNA, and other new modality manufacturing.

Support biologics/molecular therapeutics drug substance consumable and raw material lifecycle management from identification and/or design through implementation for single-use GMP manufacturing (fit for process use).

Track, trend, and analyze data for compliance, product quality, continuous improvement, and day-to-day investigations/troubleshooting activities.

Requirements:

Minimum B.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 3+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical) OR M.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 1+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical)

Previous experience leading cross-department facility and/or site improvement projects, a plus

Problem-solving (Lean Six Sigma) and change management methodologies consistent with a culture of continuous improvement is preferred

Must be proficient in operation and troubleshooting of a wide variety of instrumentation and data systems

Ability to provide ideas, introduce new technology, and drive process improvements

Work with other groups to develop, qualify, and transfer methods accordingly

Ability to cross-train on techniques across multiple groups

Why Catalent:

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Join us in making a difference.

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