MSAT Engineer I

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. 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.
• Strong communication skills.
• Detail oriented independently motivated and possess strong problem-solving abilities.

The annualized salary range for this position is $73700.00 - $84700.00.