MSAT Engineer I: GMP Manufacturing & Process Transfer

Nitto Avecia; Milford (MA); On-site; USD 74,000 - 85,000; Full time

Job summary

Nitto Avecia in Milford, MA is seeking an MSAT Engineer to provide technical transfer expertise for moving development processes into GMP manufacturing. You will collaborate with Project Teams, Manufacturing, QA, Process Engineering and Facilities to advance process transfer and resolve complex technical issues in a cGMP setting.

The role requires strong troubleshooting, on-the-floor oversight, documentation of investigations and SOP/PBR updates, plus support for new equipment onboarding and

Qualifications

• A degree in Engineering or equivalent direct experience is required.
• 0-2 years of manufacturing support experience.
• Strong mechanical aptitude and a fundamental understanding of engineering principles to perform basic troubleshooting.
• Experience in a cGMP manufacturing environment with familiarity in quality change systems is preferred.
• Must demonstrate strong technical troubleshooting and mechanical ability.
• Experience troubleshooting automated skidded system is 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.

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

Strong mechanical aptitude

Technical troubleshooting

Documentation drafting

Communication skills

Problem-solving abilities

Attention to detail

cGMP manufacturing exposure

Education

Bachelor's degree in Chemical/Mechanical/Electrical engineering

Job description

Nitto Avecia in Milford, MA is seeking an MSAT Engineer to provide technical transfer expertise for moving development processes into GMP manufacturing. You will collaborate with Project Teams, Manufacturing, QA, Process Engineering and Facilities to advance process transfer and resolve complex technical issues in a cGMP setting.

The role requires strong troubleshooting, on-the-floor oversight, documentation of investigations and SOP/PBR updates, plus support for new equipment onboarding and