Engineer II, Validation

ModernaTX • Norwood, MA

7d • Onsite

About The Position

The Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance. Here’s What You’ll Do Perform commissioning, qualification, and validation activities for Moderna’s GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities. Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met. Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards. Support new equipment qualification activities for capital and operational projects. Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments. Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.). Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program. Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs. Drive results by owning and completing validation initiatives / projects against identified timelines. Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities. Additional duties as may be assigned from time to time Here’s What You’ll Need (Basic Qualifications) B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master’s degree in above discipline preferred. Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments Here’s What You’ll Bring to the Table (Preferred Qualifications) Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE). Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection. 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. 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. 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 manager. Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Requirements

• B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.).
• Master’s degree in above discipline preferred.
• Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments

Nice To Haves

• Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).
• Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.
• 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.
• 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.
• 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 manager.
• Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Perform commissioning, qualification, and validation activities for Moderna’s GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.
• Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met.
• Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards.
• Support new equipment qualification activities for capital and operational projects.
• Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.).
• Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program.
• Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
• Drive results by owning and completing validation initiatives / projects against identified timelines.
• Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
• Additional duties as may be assigned from time to time

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees