GMP Biologics Manufacturing Support Engineer

Stark Pharma Solutions Inc; Green Bay (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Manufacturing Support Engineer in Wisconsin to provide hands-on technical support for manufacturing operations.

You will assist with equipment, facilities, utilities, unit operations, troubleshooting, and production activities to ensure safe and compliant manufacturing. The candidate will have a bachelor's degree in engineering or related field and 5+ years of regulated manufacturing experience, with solid GMP knowledge and experience in deviations, CAPA,

Qualifications

• Bachelor's degree or equivalent in engineering or related field.
• 5+ years of experience in regulated manufacturing.
• Experience with deviations, CAPA, and change control; GMP knowledge.

Responsibilities

• Provide daily technical support on the manufacturing floor.
• Support equipment setup, startup, operation, and shutdown.
• Troubleshoot equipment and process issues; perform root cause analysis.
• Support facilities, utilities, mechanical, and automation issues.
• Review batch records, SOPs, and work instructions; ensure GMP compliance.
• Collaborate with QA, QC, MS&T, Validation, and Facilities teams; communicate issues and actions.

Skills

GMP Manufacturing

Equipment Troubleshooting

Biologics Knowledge

Root Cause Analysis

Deviations / CAPA

Communication Skills

Education

Bachelor's degree in Engineering/ Biotechnology/ Chemical/ Mechanical/ Industrial

Job description

Stark Pharma Solutions Inc. is seeking a Manufacturing Support Engineer in Wisconsin to provide hands-on technical support for manufacturing operations.

You will assist with equipment, facilities, utilities, unit operations, troubleshooting, and production activities to ensure safe and compliant manufacturing. The candidate will have a bachelor's degree in engineering or related field and 5+ years of regulated manufacturing experience, with solid GMP knowledge and experience in deviations, CAPA,