Computer System Validation Lead

Merican Inc; Boston (MA); Hybrid; USD 110,000 - 165,000; Full time

Job summary

Merican Inc. is seeking a Computer System Validation Lead in Boston, MA, with a hybrid work model (3 days on-site). The role focuses on leading CSV activities to ensure GxP systems are fit for intended use and compliant with regulatory expectations.

You will define risk-based validation strategies across the system lifecycle, integrate validation with SDLC, and support data integrity and audit readiness. Collaboration with diverse teams is essential to deliver compliant validated systems.

Qualifications

• Strong grounding in CSV, GAMP, SDLC and agile delivery models.
• Practical experience with computer system assurance, risk based validation and testing per ICH Q9.

Responsibilities

• Lead computer system validation activities to ensure GxP systems are fit for intended use and compliant with regulatory expectations.
• Define and apply risk-based validation and testing strategies across system life cycle.
• Ensure validation is integrated with SDLC and delivery models while maintaining compliance.
• Support data integrity, audit readiness and ongoing compliance across regulated systems.
• Lead validation workstream within projects, ensuring timely delivery, quality outcomes and stakeholder alignment.
• Design validation documentation and traceability matrices and oversee change management for validated systems.

Skills

CSV knowledge

GAMP

SDLC

Agile delivery

Regulatory knowledge

Job description

Role-Computer System Validation Lead

Location-Boston, MA/hybrid, 3 days a week

Responsibilities:

• Lead computer system validation activities to ensure GxP regulated systems are fit for intended use and compliant with regulatory expectations.
• Define and apply risk-based validation and testing strategies across system life cycle.
• Ensure validation is effectively integrated with SDLC and delivery models while maintaining compliance
• Support data integrity, audit readiness and ongoing compliance across regulated systems
• Lead validation workstream within projects, ensuring timely delivery, quality outcomes and stakeholder alignment.
• Design validation documentation, traceability matrix and oversee change management for validated systems.

Qualifications:

• Strong grounding in CSV, GAMP, SDLC and agile delivery models
• Practical experience with computer system assurance, risk based validation and testing methodologies as per ICH Q9.
• Ability to translate regulatory expectations into pragmatic, scalable validation approaches.
• Demonstrating technical capabilities and professional knowledge of validating AI models.
• Solid understanding of GxP regulations including 21 CFR Part 11, Annex 11, and data integrity guidance.
• Effectively working on teams with diverse skills and backgrounds.
• Clear, structured communication and strong documentation skills.