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Senior Process Engineer

Senior Process Engineer

CompanyModerna
LocationNorwood, MA, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s, Master’s
Experience LevelSenior

Requirements

  • Requires a Master’s degree in Mechanical Engineering, Electrical Engineering, Computer Science or related field and 6 years of experience as a Sr Mechanical Engineer, Sr. Manufacturing Engineer, Sr. Process Engineer, or related position.
  • Alternatively, employer will accept a Bachelor’s degree in fields specified and 8 years progressive, post-baccalaureate experience in the specified roles.
  • Experience must include: Machine Maintenance; Good Manufacturing Practice (GMP); Advanced data analysis; Quality System Experience, including inspection readiness; Project management in a pharmaceutical or medical device capacity.

Responsibilities

  • Provide direct engineering support and Subject Matter Expertise for process equipment, including but not limited to continuous improvement initiatives with a focus on safety, reliability and process efficiency; creating and sustaining the preventative maintenance plans and spare parts lists; and equipment upgrades/modifications to support manufacturing needs.
  • Drive results by owning and completing projects including high-quality technical writing within the required quality systems, and meeting project timelines to ensure the production schedule is not impacted.
  • Collaborate with key stakeholders and lead cross-functional project teams through all phases of engineering project related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and equipment.
  • Troubleshoot equipment to determine root cause of failure modes and independently drive failure resolution by owning the associated Deviations, Corrective/Preventative Actions (CAPAs) and change controls.
  • Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
  • Maintain Engineering Turnover Packages, including specification, component lists, operating manuals, and drawings for GMP process equipment.
  • May supervise and lead Process Engineers responsible for manufacturing support.

Preferred Qualifications

    No preferred qualifications provided.