Senior CQV Engineer — GMP Validation & Commissioning

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

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.