Sr. Engineer I, Process Engineering, LS Plasmid
ModernaTX, Inc.

Job Info

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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 skills required.
  
• Demonstrated ability to manage own time and deliver to program timelines.
  
• Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.
  
• Proven ability to multitask.
  
• Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.
  
• Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.
  
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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