MSAT Engineer I

Avecia Pharma; Milford (MA); Hybrid; USD 73,000 - 85,000; Full time

Job summary

Avecia Pharma in Milford, MA, seeks an MSAT Engineer to bring development transfers into GMP manufacturing. Working with project teams, manufacturing, QA, process engineering, and facilities, you will apply scientific and regulatory expertise to resolve complex problems in a cGMP environment.

The role demands multi-tasking, adaptability, and hands-on on-the-floor oversight, with a focus on equipment performance, process optimization, and accurate documentation of investigations and CAPAs.

Qualifications

• A degree in Engineering or equivalent direct experience is required. Bachelors 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.

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

Fundamental engineering principles

Technical troubleshooting

Documentation drafting

Detail oriented

Independent motivation

Problem solving

Education

Bachelors degree in Chemical, Mechanical, or 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.