Senior Process Engineer - Manufacturing Sciences & Technology
Catalent · Madison, WI
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Role summary
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.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Phenom, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Catalent's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.