Process Engineer
1 day ago
Catalent Biologics is seeking a highly motivated and experienced Process Engineer to join our team in Madison, WI. As a Process Engineer, you will be responsible for supporting the development and implementation of biologics manufacturing processes, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
Key Responsibilities:
* Support technology transfer of processes into manufacturing for both internally and externally developed processes.
* Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
* Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
* Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
* Author and review documents including batch production records, tech transfer reports, 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.
Requirements:
* MS or BS in engineering, biotechnology, or a related field with at least 0 to 2 years of biopharmaceutical process development and/or manufacturing experience.
* Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.
* Advanced understanding of instrument operations and troubleshooting skills in multiple techniques.
* Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
Why Catalent:
Catalent is a global leader in the development and manufacture of pharmaceuticals, biologics, and consumer health products. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. Our team is passionate about delivering high-quality products and services to our customers, and we are committed to making a positive impact on the communities we serve.
What We Offer:
* Competitive salary and benefits package
* Opportunities for professional growth and development
* Collaborative and dynamic work environment
* Recognition and rewards for outstanding performance
How to Apply:
If you are a motivated and experienced Process Engineer looking for a new challenge, please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you
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