Biomanufacturing Compliance Lead Investigator

Catalent; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits (

Tuition reimbursement

Competitive PTO and 8 paid holidays

Job summary

Catalent's Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing Compliance, Lead Investigator to author and revise deviation records and cGMP documents. You will support audits, participate in inspection readiness, and drive continuous improvement in a fast-paced biomanufacturing environment.

The role is Monday–Friday, 9am–4pm, onsite in Madison, WI, with close collaboration across manufacturing and quality systems to ensure timely, accurate documentation and regulatory

Qualifications

• Experience in deviation writing and with Root Cause Analysis.
• Proficiency with TrackWise, ComplianceWire, JD Edwards, and Unicorn.
• Ability to apply cGMP principles to ensure compliant execution.

Responsibilities

• Author and revise deviation records, preventive actions, and related cGMP documents.
• Develop familiarity with upstream/downstream processes and facilities.
• Track and monitor open investigations with status updates.
• Contribute to improving process compliance culture and cGMP understanding.
• Participate in Inspection Readiness activities and teams.
• Guide writing and revision of Standard Operating Procedures when gaps are found.
• Assist in supporting internal and client audits.
• Exhibit professional behavior and align with company policies.
• Attend team meetings and perform other duties as assigned.

Skills

Deviation writing

Root Cause Analysis

CAPA

cGMP knowledge

Microsoft Office

TrackWise

ComplianceWire

JD Edwards

Unicorn

Education

Bachelor's degree in STEM

Associate’s degree in STEM

High School Diploma or GED

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

Catalent's Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing Compliance, Lead Investigator to author and revise deviation records and cGMP documents. You will support audits, participate in inspection readiness, and drive continuous improvement in a fast-paced biomanufacturing environment.

The role is Monday–Friday, 9am–4pm, onsite in Madison, WI, with close collaboration across manufacturing and quality systems to ensure timely, accurate documentation and regulatory