Manufacturing Process Specialist

2 weeks ago


Madison, Wisconsin, United States Catalent Inc Full time
Position Overview:
As a key member of the Manufacturing Sciences and Technology (MS&T) team, the Process Engineer will play a vital role in facilitating the transition of innovative processes into manufacturing environments for both internal and external projects.

Key Responsibilities:
  • Collaborate across various departments including Process Development, Quality Assurance, and Project Management to ensure seamless process transfer and maintenance.
  • Work closely with manufacturing teams to create and manage essential batch documentation while providing technical guidance related to GMP operations.
  • Lead the collection and analysis of process data, effectively communicating project updates and identifying trends.
  • Assess current processes to pinpoint areas for enhancement, driving efficiency and market competitiveness.
  • Draft and review critical documents such as production records, technical transfer reports, and engineering specifications.
  • Serve as the primary technical resource for risk assessments, gap analyses, and corrective actions, ensuring thorough root-cause analysis and resolution strategies.
  • Perform additional duties as required to support operational excellence.

Candidate Qualifications:
The ideal candidate will possess:
  • A Master's degree in engineering, biotechnology, or a related discipline with up to 2 years of experience in biopharmaceutical process development or manufacturing.
  • A Bachelor's degree in engineering, biotechnology, or a related field with 3 to 6 years of relevant experience.
  • An Associate degree in a related area with 6 to 9 years of experience in biopharmaceutical processes.
  • Experience in Upstream and Downstream processes, including mammalian cell culture and chromatography, as well as familiarity with molecular therapeutics.
  • Proficiency in the design and troubleshooting of single-use consumables and manufacturing equipment.
  • Strong technical acumen and hands-on experience in biological manufacturing within a GMP framework.

Why Consider Catalent:
At Catalent, we offer a structured career path, competitive compensation, and a diverse, inclusive workplace culture. Our employees enjoy:
  • Comprehensive benefits from day one, including medical, dental, and vision coverage.
  • Generous paid time off and holiday allowances.
  • 401K matching and tuition reimbursement programs.
  • Opportunities for professional growth within a global leader in drug development and delivery.

Catalent is dedicated to enhancing lives through innovation and excellence in the biopharmaceutical industry.

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