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

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Manufacturing Support Engineer

Position: Manufacturing Support Engineer
Location: Wisconsin
Duration: Long Term

Job Overview

We are seeking a Manufacturing Support Engineer to provide hands-on technical support for manufacturing operations. The role will support equipment, facilities, utilities, unit operations, troubleshooting, and production activities to ensure safe, compliant, and reliable manufacturing.

Key Responsibilities

• Provide daily technical support on the manufacturing floor.
• Support equipment setup, startup, operation, and shutdown.
• Troubleshoot equipment and process issues.
• Support facility, utility, mechanical, and automation issues.
• Analyze equipment and process data.
• Identify root causes and corrective actions.
• Partner with Maintenance and Engineering teams.
• Support real-time manufacturing troubleshooting.
• Serve as SME for assigned equipment and unit operations.
• Support single-use technologies and manufacturing systems.
• Assess raw material and consumable compatibility.
• Monitor equipment and process performance.
• Support manufacturing readiness activities.
• Review batch records, SOPs, and work instructions.
• Support deviations, investigations, CAPAs, and change controls.
• Perform root cause analysis and risk assessments.
• Collect and document technical investigation data.
• Ensure documentation meets GMP requirements.
• Work with QA, QC, MS&T, Validation, and Facilities teams.
• Provide technical updates during production meetings.
• Communicate issues and recommended actions clearly.
• Provide technical guidance to operators.
• Support equipment and process training.
• Share lessons learned and best practices.
• Support manufacturing handoffs between shifts.
• Identify opportunities to improve reliability and efficiency.

Required Qualifications

• Bachelor's degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Engineering, or related field.
• 5+ years of experience in regulated manufacturing.
• Experience with cell culture, purification, mRNA, biologics, or similar processes.
• Hands-on manufacturing equipment troubleshooting experience.
• Strong knowledge of GMP manufacturing.
• Experience with deviations, CAPA, and change control.
• Experience with root cause analysis and investigations.
• Ability to analyze technical and process data.
• Strong knowledge of manufacturing equipment and unit operations.
• Strong communication and teamwork skills.
• Ability to work in a fast-paced manufacturing environment.
• Ability to respond to urgent technical issues.

Key Skills

• GMP Manufacturing
• Equipment Troubleshooting
• Biologics Manufacturing
• Deviation / CAPA / Change Control
• Root Cause Analysis
• Equipment & Process Support

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.