Biomanufacturing Training & Compliance Lead

Ourlivesmadison; Madison, Northern (WI, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Onsite training opportunities

Job summary

Catalent's Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing, Training to help design and deliver training programs that ensure quality and compliance in a GMP biomanufacturing setting.

The role focuses on tracking training, leading sessions, developing SOPs, and collaborating with subject matter experts to support continuous improvement while maintaining operational excellence on a 2pm–10pm shift, onsite in Madison, WI.

Qualifications

• Requires GMP training knowledge and ability to apply GMP principles.
• Capable of managing training programs and mentoring staff.
• Experience authoring SOPs and related documentation under guidance.
• Strong English reading/writing and ability to communicate clearly.

Responsibilities

• Track and monitor training, provide accurate reports for compliance.
• Lead training sessions for employees.
• Develop qualifications and evaluations for training effectiveness in manufacturing.
• Assist in developing SOPs and training materials for new processes and systems.
• Collaborate with SMEs to identify needs and performance standards.
• Support quality system evaluations related to cGMP and training requirements.

Skills

GMP knowledge

Training program management

CAPA experience

SOP authoring

English literacy

Education

High School Diploma or GED

Associate’s degree in STEM

Bachelor’s degree in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

Catalent's Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing, Training to help design and deliver training programs that ensure quality and compliance in a GMP biomanufacturing setting.

The role focuses on tracking training, leading sessions, developing SOPs, and collaborating with subject matter experts to support continuous improvement while maintaining operational excellence on a 2pm–10pm shift, onsite in Madison, WI.