MSAT Engineer I

About the Role

The role of the MSAT Engineer is to provide technical expertise for the transfer of development processes into GMP manufacture. This involves working with Project Teams, Manufacturing, QA, Process Engineering, and Facilities to progress process transfer. The MSAT Engineer will utilize 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.

Requirements & Tech Stack

• 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 systems 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.