Manufacturing Support Engineer

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 – Wisconsin (Long‑Term).

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.

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