MSAT Engineer I: GMP Process Transfer & Troubleshooting

Nitto Denko Corp.; Milford (AR); On-site; USD 74,000 - 85,000; Full time

Job summary

Nitto Denko Corp. is seeking an MSAT Engineer to provide technical transfer expertise for GMP manufacture. You will work with project teams across manufacturing, QA, process engineering, and facilities to advance transfers, resolve complex issues, and ensure compliant documentation.

Responsibilities include on-the-floor process oversight, equipment onboarding, staff training, and SOP/PBR development. A engineering degree and 0-2 years in manufacturing support are expected, with strong

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical engineering preferred.
• 0-2 years of manufacturing support experience.
• Strong mechanical aptitude and engineering fundamentals.
• Experience in a cGMP manufacturing environment.
• Ability to draft clear documentation for manufacturing, procurement and quality compliance.
• Strong communication and problem-solving skills.
• Experience with automated skidded systems.

Responsibilities

• Troubleshoot, stabilize, and correct issues, with oversight, that arise relative to process execution or equipment performance to assure minimal downtime.
• On-the-floor oversight of Manufacturing process; including off-hours support when needed.
• Support the onboarding of new equipment.
• Support the training and qualification of manufacturing staff on key manufacturing processes and equipment.
• Assist the manufacturing team with improving the efficiency of set up and utilization of manufacturing assets.
• Develop, review and revise SOPs as required to assure documentation reflects current operations, meets industry standards, and meets customer expectations.
• Develop, review and revise Production Batch records (PBRs) as required to assure documentation reflects current operations, meets industry standards, and meets customer expectations.
• Develop and review quality and safety investigations.
• Provide written accounts of technical investigations and, when needed, corrective and/or preventive actions required for resolution.
• Improve process equipment design to lower or eliminate process variation and to improve product quality.
• Support Campaign Summary Reports.

Skills

Engineering degree

Mechanical aptitude

Troubleshooting

Documentation

Communication

GMP knowledge

On-floor oversight

Education

Engineering degree

Tools

Quality change mgmt systems

Automated skidded systems

Job description

Nitto Denko Corp. is seeking an MSAT Engineer to provide technical transfer expertise for GMP manufacture. You will work with project teams across manufacturing, QA, process engineering, and facilities to advance transfers, resolve complex issues, and ensure compliant documentation.

Responsibilities include on-the-floor process oversight, equipment onboarding, staff training, and SOP/PBR development. A engineering degree and 0-2 years in manufacturing support are expected, with strong