Manufacturing Support Engineer

Novozen Healthcare LLC; Wisconsin; On-site; USD 85,000 - 110,000; Full time

Job summary

Novoz en Healthcare LLC in Wisconsin is seeking a Manufacturing Support Engineer to provide hands-on technical support on the manufacturing floor in a GMP biologics environment. You will troubleshoot equipment and processes, support production operations, and help minimize downtime.

Ideal candidates bring a BS in engineering or related field and 5+ years of biologics manufacturing experience, with strong problem-solving and teamwork skills to collaborate across Manufacturing, Quality,

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, or related field.
• 5+ years of experience in cell culture, purification, mRNA, or biologics manufacturing.
• Strong manufacturing equipment and process troubleshooting experience.
• Knowledge of GMP, deviations, investigations, CAPA, and change control.
• Strong problem-solving, RCA, communication, and teamwork skills.

Responsibilities

• Provide daily technical support to manufacturing operations and operators.
• Support equipment setup, startup, operation, and shutdown.
• Troubleshoot equipment, mechanical, process, automation, and utility issues.
• Act as an SME for manufacturing equipment, systems, and unit operations.
• Perform root cause analysis and recommend corrective actions.
• Support deviations, investigations, CAPA, change controls, and risk assessments.
• Analyze equipment/process data and improve reliability and efficiency.
• Work with Manufacturing, Quality, Maintenance, Facilities, Validation, Automation, and Engineering teams.
• Support SOPs, batch records, work instructions, and technical documentation.
• Provide technical guidance and training to operators.

Skills

Cell culture

Purification

mRNA

Biologics manufacturing

Troubleshooting

Root cause analysis

Education

Bachelor's degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, or related field

Job description

Job Title: Manufacturing Support Engineer

Location: Wisconsin

Job Summary:

Seeking a Manufacturing Support Engineer to provide hands-on technical support on the manufacturing floor in a GMP biologics manufacturing environment. The role will troubleshoot equipment and process issues, support production operations, and help minimize downtime.

Key Responsibilities:

• Provide daily technical support to manufacturing operations and operators.


• Support equipment setup, startup, operation, and shutdown.


• Troubleshoot equipment, mechanical, process, automation, and utility issues.


• Act as an SME for manufacturing equipment, systems, and unit operations.


• Perform root cause analysis and recommend corrective actions.


• Support deviations, investigations, CAPA, change controls, and risk assessments.


• Analyze equipment/process data and improve reliability and efficiency.


• Work with Manufacturing, Quality, Maintenance, Facilities, Validation, Automation, and Engineering teams.


• Support SOPs, batch records, work instructions, and technical documentation.


• Provide technical guidance and training to operators.

Requirements:

• Bachelor's degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, or related field.


• 5+ years of experience in cell culture, purification, mRNA, or biologics manufacturing.


• Strong manufacturing equipment and process troubleshooting experience.


• Knowledge of GMP, deviations, investigations, CAPA, and change control.


• Strong problem-solving, RCA, communication, and teamwork skills.