Sr. Engineer, Commissioning, Qualification, and Validation

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 130,800 - 209,400; Full time

Benefits offered by this job

Best healthcare coverage

Well-being resources

Family planning benefits

Generous paid time off

Savings and investment opportunities

Location-specific perks

Job summary

ModernaTX, Inc. in Norwood, Massachusetts, seeks a Senior Engineer for Commissioning, Qualification and Validation to lead CQV activities at our GMP facility.

You will own validation of facilities, utilities, equipment, and processes, ensuring compliance with internal procedures and regulatory standards. This role requires a life sciences degree and 5 years of CQV or related experience; duties include IQ/OQ/PQ, change controls, deviations, CAPAs, and cross-functional collaboration.

Qualifications

• Requires a Bachelor's degree in Pharmaceutical Sciences or related life science field.
• Minimum 5 years of progressive post-baccalaureate experience in CQV/validation in a cGMP manufacturing environment.
• Experience writing IQ, OQ, and PQ protocols and reports.
• Experience authoring validation-related change controls, deviations, and investigations.
• Knowledge of manufacturing equipment and testing methods.

Responsibilities

• Manage commissioning, qualification, and validation activities for GMP facility.
• Ensure validated status of facilities, utilities, equipment, and processes is established and maintained per internal procedures and regulatory standards.
• Track and report metrics for the re-qualification program and ensure stakeholder commitments.
• Own quality records (Change Controls, Deviations, CAPAs) and continuous improvement initiatives.
• Lead deviation investigations related to equipment, utilities, automation, and laboratory instruments.
• Provide validation SME support for equipment and systems (including temperature-controlled units, analytical instruments, and unit operations).
• Participate in cross-functional teams to meet timelines for validated processes and systems.
• Review contractor deliverables and manage priorities in CQV scope.
• Drive results by completing validation initiatives on schedule.
• May telecommute up to 30%.

Skills

IQ/OQ/PQ protocols

Validation experience

CAPA/Deviations

Continuous improvement

Equipment knowledge

Education

Bachelor's degree in Pharmaceutical Sciences or related life science

Job description

The Role:

ModernaTX, Inc. seeks a Sr. Engineer, Commissioning, Qualification, and Validation for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• 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.
• May telecommute up to 30%.

Here’s What You’ll Bring to the Table:

Minimum 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.
• 5 years of experience must include:
• Writing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Reports;
• Authoring Validation-related Change Controls, Deviations, and Investigations;
• Executing Validation activities across various projects;
• Applying Continuous Improvements to periodic review and requalification programs; and
• Applying manufacturing equipment knowledge to understand and develop testing requirements.
• May telecommute up to 30%.

The salary range for this role is $130,800 to $209,400. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular 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.

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Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, 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
• Savingsandinvestmentsto 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.