Principal Engineer, Process Engineering DS
ModernaTX, Inc.

Job Info

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The Role:
Moderna is seeking a Director, Process Engineering - Drug Substance based in Norwood, MA.

Reporting to the Sr. Director of F&E, the Director, Process Engineer DS will be responsible for ensuring operability and reliability of GMP drug substance manufacturing process equipment located at the Moderna manufacturing facilities. This individual will work with closely with Facilities 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.

Demonstrated project management skills, in particular engineering and qualification projects from conception to completion. Proven problem-solving skills with a pro-active, field-based approach for project and deviation management required. Ability to develop and drive continuous improvement initiatives is essential. Strong technical writing, problem solving skills, data analysis, and development and implementation of effective corrective and preventative action based on investigations is required.

Here's What You'll Do:

• Supervise and lead Process Engineers responsible for Drug Substance Manufacturing support for the Moderna Norwood MTC Campus. Provide technical guidance, coaching, and work prioritization assistance with cross functional engineering teams.
  
• Provide direct engineering support and Subject Matter Expertise for drug substance process equipment in use (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.). This includes serving as the Engineering owner for process equipment.
  
• Drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.
  
• The Process Engineer will participate on 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.
  
• Troubleshooting equipment to determine root cause of failure modes, owning Corrective/Preventative Actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
  
• The candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from their supervisor, in addition to reviewing and guiding the work and performance of contractors.
  
• Supports regulatory audits with coaching from subject matter experts.
  
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
  
• Provide project management of initiatives within Process Engineering. Practices and promotes safe work habits and adheres to safety procedures and guideline
  

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

• Bachelor's degree in Chemical or Mechanical Engineering
  
• Minimum of 10 years relevant experience as a Process Engineer
  
• 10 years of experience in a GxP biopharmaceutical operations 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.
  
• A comprehensive understanding of regulatory requirements and their applications in a cGMP 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.
  
• Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements
  
• Experience interacting with representatives of regulatory agencies
  
• Experience with facility, utility, systems, and equipment commissioning and qualification
  
• Excellent written and oral English language skills
  
• Project management experience
  
• People management experience
  

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 winter shut down
  • 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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