Biologics Manufacturing Technical Support Specialist

Creative Solutions Services, LLC; Madison (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Madison, WI seeks a Manufacturing Technical Support / Deviations Specialist with GMP biologics experience to troubleshoot, support deviations, CAPA, change controls, and process improvement across clinical and commercial manufacturing, collaborating with Quality, Process Development, QC, Engineering, and other functions.

You will draft SOPs, analyze process data, support technology transfer, and address equipment issues including single-use systems and

Qualifications

• 5+ years of biopharmaceutical/biologics manufacturing or technical support.

Responsibilities

• Provide real-time technical support and advanced troubleshooting for GMP manufacturing processes.

Skills

Strong communication

Problem solving

Technical writing

Cross-functional collaboration

Microsoft Office

Education

STEM degree (Assoc/Bach/Master)

Tools

TrackWise

ComplianceWire

Unicorn

Job description

Creative Solutions Services, LLC in Madison, WI seeks a Manufacturing Technical Support / Deviations Specialist with GMP biologics experience to troubleshoot, support deviations, CAPA, change controls, and process improvement across clinical and commercial manufacturing, collaborating with Quality, Process Development, QC, Engineering, and other functions.

You will draft SOPs, analyze process data, support technology transfer, and address equipment issues including single-use systems and