Biomanufacturing Compliance Lead I (Night Shift)

Catalent Pharma Solutions; Madison (WI); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Tuition Reimbursement

Paid time off + 8 holidays

Job summary

Catalent, a leader in biopharmaceutical development and manufacturing, is hiring an Associate Lead I - Biomanufacturing, Compliance in Madison, WI. The role focuses on supporting cGMP operations, ensuring SOP adherence, and upholding regulatory and client requirements.

The position is 100% onsite with a Wednesday–Saturday night shift, offering a sign‑on bonus and opportunities to contribute to continuous improvement and patient safety within a fast‑paced GMP environment.

Qualifications

• 4+ years of related experience with a high school diploma or GED, or a STEM degree with minimal experience.
• Fundamental knowledge of manufacturing and laboratory operations.
• Experience with deviation investigations and CAPAs.
• Experience with authoring and editing SOPs under guidance.

Responsibilities

• Facilitate Rapid Response Team during deviations and document root cause information.
• Review logbooks for cGMP compliance and track investigations.
• Participate in CAPA programs and internal audits.
• Assist in SOP development for new processes or equipment.
• Support on‑floor safety improvements and GMP training needs.

Skills

cGMP principles

CAPA investigations

SOP authoring

Quality systems

Education

Bachelor's degree in STEM

Associate's degree in STEM

High School Diploma/GED with experience

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Microsoft Office

Job description

Catalent, a leader in biopharmaceutical development and manufacturing, is hiring an Associate Lead I - Biomanufacturing, Compliance in Madison, WI. The role focuses on supporting cGMP operations, ensuring SOP adherence, and upholding regulatory and client requirements.

The position is 100% onsite with a Wednesday–Saturday night shift, offering a sign‑on bonus and opportunities to contribute to continuous improvement and patient safety within a fast‑paced GMP environment.