KH
Sr. Computer Systems Validation Analyst
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
2 weeks ago
- GxP
- SCADA
- FactoryTalk
- PLC
- Ignition
- Technical Writing
2 weeks ago
We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems.
The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification protocols (IQ/OQ/PQ). The candidate will work closely with engineering, automation, quality, IT, and business teams to ensure systems remain compliant and validated.
Roles & Responsibilities:
- Plan, lead, and execute CSV activities for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems.
- Develop and review URS, FS, DS, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Summary Reports.
- Author and maintain documentation for GxP computerized systems.
- Apply GAMP 5 principles throughout the computer system validation lifecycle.
- Execute software/system validation test protocols and document results.
- Manage change controls for existing qualified systems.
- Assess system changes and determine validation impact.
- Prepare/revise validation documentation based on system changes.
- Ensure compliance with 21 CFR Part 11 and EU Annex 11.
- Manage deviations, issues, CAPAs, and validation discrepancies.
- Develop and execute test protocols and maintain proper evidence/documentation.
- Maintain project schedules and ensure validation deliverables are completed on time.
- Collaborate with Automation, Engineering, QA, IT, Manufacturing, and business stakeholders.
- 5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharmaceutical/Biotech environments.
- Strong experience validating SCADA, PLC, Rockwell FactoryTalk, and/or Ignition systems.
- Hands-on experience with GAMP 5 and risk-based validation approaches.
- Strong knowledge of 21 CFR Part 11 and EU Annex 11.
- Experience with change control and system requalification.
- Experience managing deviations, issues, CAPAs, and corrective actions.
- Strong understanding of GxP computerized systems and regulated manufacturing environments.
- Excellent technical writing and documentation skills.
- Strong communication and project coordination skills.
Sr. Computer Systems Validation Analyst · Katalyst Healthcares & Life Sciences