Computer Systems Validation Specialist
Kindeva Drug Delivery · St Louis, MO · 3 wk ago
On-siteInformation TechnologyFull-time
Responsibilities
- Lead and/or support validation activities for GxP computerized systems including MES, SCADA/PLC, LIMS, EM systems, and serialization/packaging systems
- Author and execute validation documentation: URS, FS/DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, Periodic Reviews / Audit Trail Reviews
- Ensure validation deliverables meet internal SOPs and regulatory expectations
- Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+
- Perform periodic reviews of validated systems
- Support FDA, EMA, and internal audits/inspections
- Assess and remediate data integrity risks
- Support system changes through formal change control processes
- Evaluate impact of updates, patches, and configuration changes
- Ensure appropriate re-validation activities
- Maintain systems in a validated state
- Apply GAMP 5 risk-based validation approach
- Lead risk assessments (FMEA, system risk ranking)
- Cross-functional collaboration with IT, QA, Manufacturing, MS&T, and Engineering
- Support system implementation and facility startup
- Support digital transformation initiatives
- Document and ensure inspection readiness
- Support responses to audit findings and regulatory observations
- Drive continuous improvement in validation processes and templates
- Support implementation of electronic validation systems (e.g., Kneat, Veeva)
Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field
- Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech environments
- Hands-on experience with Part 11 / Annex 11 compliance
- Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+
- Familiarity with MES, ERP, LIMS, SCADA/PLC systems
- Understanding of system architecture, interfaces, backup, disaster recovery, and cybersecurity
- Experience in aseptic/sterile injectable manufacturing preferred
- Multi-site validation program experience preferred
- Familiarity with serialization, AVI systems, and cold storage monitoring preferred
- Experience with Kneat, ValGenesis, or Veeva is desirable