MSAT Engineer I

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

About this opportunity :

The role of the MSAT Engineer is to provide technical expertise of transfer of development processes into GMP manufacture. Working with Project Teams, Manufacturing, QA, Process Engineering, and Facilities to progress process transfer. Utilizing scientific, process, and necessary regulatory expertise to quickly understand complex concepts, taking a leading position in resolving technical problems in a cGMP production environment. The ability to multi-task and accommodate shifting priorities is a must.

Key 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

Required Skills/Abilities:

• A degree in Engineering or equivalent direct experience is required. Bachelor’s degree in Chemical, Mechanical, or Electrical engineering preferred.
• 0-2 years of manufacturing support experience.
• Demonstrates a strong mechanical aptitude as well as a fundamental understanding of engineering principals to perform, with oversight, basic troubleshooting and diagnostics of equipment and instrument issues.
• Experience in cGMP manufacturing environment with familiarity in quality change management systems preferred.
• Must demonstrate strong technical troubleshooting and mechanical ability.
• Experience troubleshooting automated skidded system preferred.
• Ability to efficiently draft clear and informative documentation for manufacturing, procurement and quality compliance.
• Strong communication skills.
• Detail oriented, independently motivated and possess strong problem-solving abilities.

The annualized salary range for this position is $73,700.00 - $84,700.00.