- Company Name
- Grove Technical Resources, INC
- Job Title
- Computer system validation
- Job Description
-
**Job Title:** Senior Quality Engineer – Computer System Validation
**Role Summary:**
Lead and oversee the validation of GxP‑regulated enterprise, laboratory, and manufacturing information systems. Apply CSA and GAMP5 principles to ensure GMP compliance, data integrity, and audit readiness across ServiceNow, Veeva QMS/EDC, ERP, and related platforms.
**Expectations:**
* Provide strategic quality oversight for critical IT systems.
* Drive risk‑based validation and lifecycle management.
* Ensure alignment with GMP, GxP, and regulatory requirements.
* Deliver high‑quality documentation and maintain audit trail integrity.
**Key Responsibilities:**
1. Lead validation activities for ServiceNow, Veeva QMS/EDC, Compass, ERP, RIM, and lab/ manufacturing systems.
2. Apply CSA and GAMP5 standards to develop, review, and approve validation plans, test scripts, reports, and traceability matrices.
3. Conduct regulatory assessments, change control reviews, and CAPA/deviation investigations.
4. Monitor data integrity, system performance, and compliance throughout the system lifecycle.
5. Collaborate with cross‑functional teams (IT, QA, Regulatory, Operations) to mitigate quality risks.
6. Maintain audit readiness and support external audits and inspections.
7. Mentor and train junior team members on validation best practices.
**Required Skills:**
* 5+ years of experience in GMP‑regulated computerized systems and CSA/CSV activities.
* Proven expertise in lab quality systems, GxP compliance, and ITIL/GAMP5 frameworks.
* Strong validation documentation, test management, and audit preparation skills.
* Excellent communication, analytical, and project management abilities.
* Ability to work independently and lead cross‑functional initiatives.
**Required Education & Certifications:**
* Bachelor’s degree in Information Technology, Computer Science, or related field.
* Minimum of 5 years in GMP‑regulated environments with CSA/CSV focus.
* Certifications in GAMP5 (or equivalent), ITIL, or related quality frameworks preferred.