Principal Process Engineer, Upstream Biologics — Onsite

Catalent

Madison (WI)

On-site

USD 150,000 - 190,000

Full time

14 days+

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Benefits offered by this job

Career development

Paid time off

Health benefits

Tuition reimbursement

Job summary

Catalent is seeking a Principal Process Engineer in Manufacturing Sciences & Technology at its Madison, WI site. The role provides on‑call and on‑the‑floor technical support for GMP manufacturing, with emphasis on technical documentation, data analysis, and cross‑functional collaboration.

The candidate will author batch records, tech transfer reports, and operating procedures, while mentoring staff and leading projects across multiple disciplines to ensure regulatory compliance and process

Qualifications

Bachelor's degree in a STEM discipline with 15+ years of related experience, or advanced degrees with substantial experience.
Experience in documenting and reporting; SOPs, batch records, and technical reports.
Statistical techniques for data analysis and reporting.
Direct personnel management and cross-functional mentoring.
Experience investigating deviations, out-of-spec results, and CAPAs.
Experience with process equipment, single-use systems, and GMP manufacturing.

Responsibilities

Develop and execute technical work plans and schedules.
Author and approve technical documents (protocols, tech transfer reports, SOPs, batch records).
Review documents for accuracy and regulatory compliance.
Train and mentor staff; lead cross-disciplinary projects.
Collaborate to transfer and maintain processes across sites.
Prepare process data presentations and identify performance trends.
Drive improvements to enhance efficiency and consistency.