Principal GxP Systems Engineer

Principal GxP Systems Engineer

Locations: Norwood, Massachusetts

Time Type: Full time

Posted on: Posted 2 Days Ago

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 processes from Tech Dev 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.
• Participate in validation activities with IT, Manufacturing, and QA related to implementation and ongoing 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 of 7+ years of experience authoring and/or executing 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.

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.

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.

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!