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Quality Engineer - CSV & Quality Systems

Job

QvalFocus Inc.

Somerville, MA (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 6/25/2026

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Job Description

Quality Engineer - CSV & Quality Systems at QvalFocus Inc. Quality Engineer - CSV & Quality Systems at QvalFocus Inc. in Somerville, Massachusetts Posted in 1 day ago.
Type:
full-time
Job Description:
We are seeking a Quality Engineer with experience in computerized systems validation and quality oversight within regulated pharmaceutical/life sciences environments. The role will support Quality Information Systems Management (QISM) initiatives across Manufacturing and Analytical Laboratory systems.
Key Responsibilities:
Provide quality oversight for enterprise and lab system projects including ServiceNow, QMS, ERP, Veeva, RIM, Manufacturing, and Lab Systems Support system validation activities including requirements, risk assessments, test scripts, execution, and traceability reviews Participate in change controls, deviations, CAPAs, periodic reviews, and system releases Ensure compliance with Data Integrity, GAMP5, and validation lifecycle requirements Collaborate with cross-functional teams to resolve quality and compliance issues Identify quality risks and support mitigation planning
Required Skills:
6-10+ years of experience in CSV/CSA, Quality Systems, or Validation Strong knowledge of GAMP5, Data Integrity, ITIL, and SDLC/validation lifecycle Experience with enterprise systems, manufacturing systems, and lab applications Strong documentation, analytical, and communication skills
Preferred:
Experience with Veeva VQMS, ServiceNow, ALM/e-signature systems Knowledge of Agile validation methodologies Bachelor's degree in IT, Computer Science, or related field

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