Full-Time

Engineer II

Quality Assurance

Updated on 12/2/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines and therapies

Biotechnology
Healthcare

Mid

Norwood, MA, USA

May telecommute up to 1 day per week.

Category
QA & Testing
Quality Assurance
Requirements
  • Requires a Master’s degree in Mechanical Engineering, Manufacturing Engineering, or related field and 1 year of experience as a Manufacturing Associate, Manufacturing Process Associate, Validation Engineer, or related position.
  • 1 year of experience must include:
  • Quality Assurance & Regulatory Compliance support;
  • Change controls;
  • Change Management and CAPA;
  • Analyzing & developing solutions for manufacturing issues; and
  • cGMP practices.
Responsibilities
  • Support manufacturing improvement initiatives and technology transfer projects.
  • Author, review, and approve Standard Operating Procedures (SOPs), policies, and batch production/testing records to ensure compliance and adherence to regulations and cGMP operations.
  • Troubleshoot manufacturing issues and evaluate solutions.
  • Identify, classify, and report deviations.
  • Oversee execution of remediation and Corrective Action Preventative Action (CAPA) activities required to continue production and/or move a process to the next milestone.
  • Work with team to determine root cause and potential preventative/corrective actions.
  • Ensure timely closure of investigations.
  • Provide quality oversight to the change management system for change controls related to new product introduction and major process changes, including providing plan creation oversight, verifying that changes adhere to SOPs, and regulatory compliance.
  • Partner with peers and cross-functional teams for process changes.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

15%

2 year growth

53%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.

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