Process Equipment Engineer II - GMP Manufacturing

BioSpace; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Job summary

Moderna is seeking an Engineer II for our Norwood, MA facility to lead and enhance cutting-edge manufacturing processes. You will serve as a technical liaison for capital projects or GMP manufacturing process equipment, focusing on reducing events, minimizing user interventions, and improving product quality and safety.

Collaborate with MS&T, Facilities, Validation, and end users to ensure timely, compliant project execution.

Qualifications

• BS or MS in Chemical or Mechanical Engineering or equivalent.
• Minimum 3 years relevant experience in Facilities, Engineering, or Operations.
• None

Responsibilities

• Provide direct engineering support and subject matter expertise for process equipment at Norwood, MA, including Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, Component Prep Equipment, and more.
• Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.
• Drive results by owning and completing small to medium-sized projects with challenging timelines and support from their manager.
• Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment.
• Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, own Corrective/Preventative Actions and associated Change Controls.
• Own and maintain process equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows).
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
• Meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines.
• Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.
• Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.
• Ensure all manufacturing activities comply with health, safety, and environmental regulations.
• Support the Process Engineering On-call team with troubleshooting guidelines and investigation.
• Assist in the setup/changeover of manufacturing systems and processes.
• Perform operational assessments to ensure procedures and tools are in place.
• Participate in internal and external audits, addressing any findings, and implementing any corrective actions.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Education

BS or MS in Chemical or Mechanical Engineering or equivalent

Job description

Moderna is seeking an Engineer II for our Norwood, MA facility to lead and enhance cutting-edge manufacturing processes. You will serve as a technical liaison for capital projects or GMP manufacturing process equipment, focusing on reducing events, minimizing user interventions, and improving product quality and safety.

Collaborate with MS&T, Facilities, Validation, and end users to ensure timely, compliant project execution.