Job Description

• We are seeking an experienced Computer Systems Validation (CSV) Engineer for a 6-month contract role in Boston, MA. The ideal candidate will play a key role in executing computer systems validation activities and ensuring compliance with regulatory requirements for quality control (QC) lab environments.

  Responsibilities :

• Execute Computer Systems Validation (CSV) activities, including requirements gathering, IQ/OQ/PQ protocol generation, test case execution, and report generation.
• Collaborate with QA teams and work closely with vendors to ensure proper validation processes are in place.
• Ensure compliance with GxP regulations , including GLP/GMP, 21 CFR Part 11, and lab systems validation.
• Manage and resolve incidents, deviations, and CAPA (Corrective and Preventive Action) processes.
• Perform onsite validation activities, coordinating with cross-functional teams to support validation efforts.
• Maintain and update validation documentation according to company SOPs and industry standards.

• Qualifications :

• 7+ years of experience in Computer Systems Validation for QC labs.
• Strong knowledge of GxP regulations , including GLP/GMP, 21 CFR Part 11 , and validation of lab systems.
• Proficient in managing incidents, deviations, and CAPA processes .
• Ability to work collaboratively with cross-functional teams and on-site.
• Bachelor's degree in Computer Science or a related field.

• Key Skills :

• CSV experience in QC Labs.
• Strong familiarity with GxP regulations and 21 CFR Part 11 .
• Knowledge of GLP/GMP environments and validation processes.
• Incident, deviation, and CAPA management .
• Onsite presence and teamwork abilities.

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