Senior Process Engineer - Manufacturing Sciences & Technology

Senior Process Engineer supporting downstream biologics manufacturing and technology transfer at Catalent's Madison biologics facility. The role involves overseeing process development handoffs to GMP manufacturing, managing cross-functional projects, and ensuring compliant, scalable operations for mammalian cell therapies and mRNA products.

Responsibilities

• Oversee technical support and technology transfer of mammalian biologic processes into manufacturing
• Develop and execute technical work plans independently using customer milestones and site standards
• Author, approve, and review technical documents including protocols, procedures, and batch records for regulatory compliance
• Lead cross-functional collaboration with Process Development, Manufacturing, Quality, and Supply Chain teams
• Identify process improvements, support risk assessments, and conduct root-cause analyses for deviations and CAPAs

Requirements

• Associate's degree in STEM with 12+ years experience, or Bachelor's with 6+, or Master's with 4+, or Doctorate
• Experience in mRNA or protein therapeutics manufacturing and late-stage/commercial production
• Demonstrated leadership managing and mentoring staff across functions
• Technical expertise in downstream processes: depth filtration, chromatography, tangential flow filtration, viral filtration
• Hands-on experience with deviations, CAPAs, change controls in cGMP-regulated environments
• Proficiency authoring and reviewing technical documentation with statistical data analysis
• Operational engineering experience with single-use systems and biologics manufacturing equipment