Principal GxP Systems Engineer

The Role

The Principal GxP Systems Engineer will serve a key role supporting the delivery and administration of the Syncade MES (Manufacturing Execution system). The individual will support and execute projects translating process requirements and MES system best practices into practical, usable electronic batch records.

Here’s What You’ll Do

• Lead the design, development, and implementation of MES solutions using the Syncade platform

• Provide technical leadership and guidance to junior engineers and project teams

• Install, configure and maintain Manufacturing Execution Systems utilizing industry best practices

• Participate in the Technical Transfer of new products and process from Tech Dev and into Manufacturing.

• Identify opportunities to improve existing processes, equipment, systems, and infrastructure by utilizing industry best practices.

• Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems

• Participates in validation activities with IT, Manufacturing, and QA related to implementation and on-going support.

• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

• Ensure compliance with regulatory requirements and industry standards

• Stay up-to-date with emerging trends and technologies in MES engineering

• Troubleshoot and resolve technical issues related to MES systems and processes

Here’s What You’ll Bring to the Table

• A bachelor’s degree in Engineering, Computer Science, or other Technical degree.

• Pharmaceutical or Biotechnology experience required

• A minimum 7+ years of experience authoring and/or execution of MES electronic Batch Records.

• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations

• An understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).

• Experience designing recipes based on ISA 95 and ISA 88 standards and best practices

• Experience with software development and programming languages such as C#, Java, or SQL

• Strong knowledge of MES concepts, including batch management, recipe management, and data collection

• Ability to provide off-hours support as necessary

• Strong leadership skills, with the ability to mentor and guide junior engineers and project teams

• 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 pa