Manager, Process Engineering (Clinical Manufacturing)
ModernaTX, Inc.

Job Info

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The Role:

The Process Engineering Manager will be responsible for ensuring operability and reliability of GMP manufacturing process equipment located at the Moderna manufacturing facility in Burlington, MA. This individual will work closely with Facilities, MS&T and Manufacturing to lead a team of engineers in investigation and troubleshooting issues related to process equipment, tech transfer and new product introduction. Applicants should enjoy working in a fast-paced, hands on, dynamic, and innovative environment.

Here's What You'll Do:

• Supervise and lead Process Engineers responsible for Manufacturing support for the Moderna Clinical Manufacturing Facility. Provide technical guidance, coaching, and work prioritization assistance.
  
• Provide direct engineering support and Subject Matter Expertise for process equipment in use with clinical processes (Ultrafiltration, Chromatography, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...). This includes serving as the Engineering owner for process equipment.
  
• Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early stage manufacturing processes
  
• Lead and manage large sized, complex projects. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.
  
• 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.
  
• Manage, prioritize and assign appropriate resources for projects requiring Process Engineering ownership
  
• Collaborate with peer Process Engineering lead functions to ensure network alignment on processes. Drive best in class communication and project execution.
  
• Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.
  
• At the level of Manager, the candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work and performance of contractors.
  
• Collaborate with Quality Assurance to streamline processes and remove obstacles to allow for agile and compliant project execution
  
• Own and ensure team compliance for quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
  

Here's What You'll Bring to the Table:

• Minimum Education Requirement: A bachelor's degree in Chemical or Mechanical Engineering
  
• Minimum of 8 years' relevant experience as a Process Engineer
  
• Minimum of 3 years' experience in a leadership role
  
• Experience in a GxP environment preferred
  
• Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)
  
• 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.
  
• 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 path forward for complex problems.
  
• Demonstrated ability to manage own time and deliver to program timelines.
  
• Proven ability to multitask.
  
• Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment
  
• Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.
  
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
  
• Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.
  

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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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