Sr. Engineer, Commissioning, Qualification, and Validation

About the role

Manage the commissioning, qualification, and validation activities for ModernaTX, Inc.’s Good Manufacturing Practices (GMP) manufacturing facility in Norwood, Massachusetts. 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.

May telecommute up to 30%.

Responsibilities

• 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 (e.g., Refrigerators, Freezers, Incubators), Analytical Instruments used for in-process and quality control testing, and Manufacturing Unit Operations (e.g., Ultrafiltration, Chromatography, Mixers, Tanks and Vessels, Bioreactors and Fermenters).
• 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.

Requirements

Requires at least a Bachelor’s degree in Pharmaceutical Sciences or related life science field and 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.

• Writing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Reports.
• Authorizing Validation-related Change Controls, Deviations, and Investigations.
• Executing Validation activities across various projects.
• Applying Continuous Improvements to periodic review and requalification programs.
• Applying manufacturing equipment knowledge to understand and develop testing requirements.

Pay

The salary range for this role is $130,800 to $209,400. The minimum target pay for this position, based on its primary location, is $170,000 to $209,400. An individual’s placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

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.

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.