Sr. Engineer, Commissioning, Qualification, and Validation

ModernaTX • Norwood, MA

1d • Hybrid

About The Position

ModernaTX, Inc. seeks a Sr. Engineer, Commissioning, Qualification, and Validation for its Norwood, Massachusetts location. This role involves managing the commissioning, qualification, and validation activities for the company’s Good Manufacturing Practices (GMP) manufacturing facility. The primary goal is to 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 and standards. The position requires tracking and reporting on metrics relevant to the re-qualification program, ensuring commitments to stakeholders are met, and owning quality records such as Change Controls, Deviations, and Corrective and Preventative Actions (CAPAs). The role also includes leading investigations for deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments. Providing validation subject matter expertise and support for various equipment and systems is crucial, including Controlled Temperature Units, Analytical Instruments, and Manufacturing Unit Operations. The Sr. Engineer will participate in multi-functional teams to meet project implementation timeframes and support continuous quality system improvements. Reviewing deliverables from contractors and consultants and managing their priorities is also a key responsibility. The role demands driving results by owning and completing validation initiatives and projects within identified timelines. The position may allow for telecommuting up to 30%.

Requirements

• Requires at least a Bachelor’s degree in Pharmaceutical Sciences or related life science field.
• 5 years of progressive post-baccalaureate experience in the position offered or as Senior Validation Engineer, Validation Engineer, CQV Engineer or related position in a cGMP manufacturing environment.
• 5 years of experience must include: Writing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Reports.
• 5 years of experience must include: Authoring Validation-related Change Controls, Deviations, and Investigations.
• 5 years of experience must include: Executing Validation activities across various projects.
• 5 years of experience must include: Applying Continuous Improvements to periodic review and requalification programs.
• 5 years of experience must include: Applying manufacturing equipment knowledge to understand and develop testing requirements.

Responsibilities

• Manage the commissioning, qualification, and validation activities for the company’s Good Manufacturing Practices (GMP) manufacturing facility.
• 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 and standards.
• Track and report status on metrics relevant to the re-qualification program activities and responsibilities, and ensure commitments to key stakeholders are met.
• Own quality records such as Change Controls, Deviations, Corrective and Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
• Lead investigation and review deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Provide validation subject matter expertise and support for equipment and systems in use, including Controlled Temperature Units such as Refrigerators, Freezers, Incubators; Analytical Instruments used for in-process and quality control testing; and Manufacturing Unit Operations including Ultrafiltration, Chromatography, Mixers, Tanks and Vessels, and Bioreactors and Fermenters, among others.
• Participate in multi-functional department teams for validated process, equipment, utilities, method, and computer systems, to meet established timeframes for project implementations that support business needs and meet global regulatory requirements.
• Participate in continuous quality system improvements and support implementing improvements in the GMP Validation and Change Control Programs.
• Review deliverables by contractors and consultants in the day-to-day execution of Commissioning, Quality and Validation (CQV) scope, and manage contractor priorities.
• Drive results by owning and completing validation initiatives and projects against identified timelines.

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
• The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• Savings and investments to help you plan for the future

What This Job Offers

• Job Type: Full-time
• Career Level: Senior