MSAT Engineer I

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

Job summary

Avecia Pharma is seeking an MSAT Engineer in Milford, MA to provide technical expertise for transferring development processes into GMP manufacturing. You will work with project teams, manufacturing, QA, and process engineering to resolve issues and support process transfer in a cGMP environment.

The role requires a degree in engineering with 0-2 years in manufacturing support, strong troubleshooting, and hands-on equipment familiarity.

Qualifications

• Bachelor's degree in Chemical, Mechanical, or Electrical engineering preferred.
• 0-2 years of manufacturing support experience.
• Strong mechanical aptitude with engineering fundamentals.
• Experience in a cGMP manufacturing environment is a plus.
• Ability to draft clear documentation for manufacturing and quality.
• Detail oriented and proactive problem-solver.

Responsibilities

• Troubleshoot, stabilize, and correct issues on the floor to minimize downtime.
• On-the-floor oversight of Manufacturing processes and off-hours support.
• Support onboarding of new equipment and training of staff.
• Assist in improving setup efficiency and utilization of assets.
• Develop and revise SOPs and Production Batch records.
• Contribute to quality and safety investigations and corrective actions.
• Provide technical investigations and action plans as needed.
• Support Campaign Summary Reports.

Skills

Manufacturing support

Troubleshooting

cGMP knowledge

Documentation

Education

Bachelor's degree in Chemical/Mechanical/Electrical engineering

Job description

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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.
• Detail oriented, independently motivated and possess strong problem-solving abilities.

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