Sr. Engineer I, Process Engineering, LS Plasmid

The Role

In this role, you will be responsible for ensuring operability and reliability of LS Plasmid GMP manufacturing process equipment located at the Moderna manufacturing facility in Norwood, MA.  This individual will work closely with Facilities, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment.  Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.

Here’s What You’ll Do

• Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA. Serve as the System Owner focusing on the lifecycle management of the equipment from procurement to decommissioning, including the development and improvement of maintenance procedures, spare parts lists, and training for technicians and manufacturing operators.

• Drive results by owning and completing continuous improvement projects centering around reliability, safety, and process efficiency, or sub-projects of large capital projects, with high-quality technical documentation within the required quality systems and meeting project timelines to ensure the production schedule is not impacted.

• Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.

• Provide technical support and execution of EHS policies, procedures, and initiatives.

• Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early and late-stage manufacturing processes as well as continuously improve the facility fit process to support new product introduction and technology transfer projects.

• Engineer new and modify existing processes to ensure right first-time process start up.

• Manage project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.

• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.

• Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into assessing change controls, and continuous improvement initiatives.

• Mentor and train a group of engineers, who can be direct reports. Assess project requests for feasibility and scope, work with management teams to determine project priority, and track resource availability and project milestones in support of direct reports. 

• Provide effective stakeholder feedback to all change controls, deviations, CAPAs and other quality documentation.

• Participate in internal and external audits, addressing any findings and implementing corrective actions.

• Support the process engineering on call team with troubleshooting guideline and investigations.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• Minimum Education Requirement: A bachelor’s degree in chemical or mechanical engineering

• Minimum of 6 years experience as a Process Engineer or similar role

• Experience with Bioprocess Equipment (Fermenters, Reaction Vessels, Ultrafiltration, Chromatography,  Single Use Mixers, Temperature Control Units, Buffer Prep Vessels, etc.)

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Minimum of 1 year experience in a leadership role.

• Experience in a GMP environment.

• Self-directed with effective analytical and problem-solving skills.  Must be able to deliver results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor. 

• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. 

• Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.  Must be able to be able to find true root cause and utilize strong decision-making skills to determine appropriate path forward for complex problems.

• Must be able to lead and manage large sized, complex projects.

• Excellent interpersonal and communication skills (verbal and written) are required.  Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.  Technical writing skil