Job Description
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated, maintained, and compliant with applicable regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
This role supports the full lifecycle of computerized systems including implementation, qualification, maintenance, periodic review, and retirement, ensuring data integrity, system reliability, and inspection readiness across multiple sites or facilities.
Responsibilities - Validation Lifecycle Execution
- 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 expectation
- Regulatory Compliance & Data Integrity
- Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
- Perform periodic reviews of validated systems
- Support FDA, EMA, and internal audits/inspections
- Assess and remediate data integrity risks
- Change Control & Lifecycle Management
- 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
- Risk-Based Validation Strategy
- Apply GAMP 5 risk-based validation approach
- Classify systems based on complexity and GxP impact
- Lead risk assessments (FMEA, system risk ranking)
- Cross-Functional Collaboration
- Partner with IT, QA, Manufacturing, MS&T, and Engineering
- Provide CSV guidance during system implementation and facility startup
- Support digital transformation initiatives
- Documentation & Inspection Readiness
- Maintain GMP-compliant validation documentation
- Ensure audit readiness and traceability
- Support responses to audit findings and regulatory observations
- Continuous Improvement
- Improve validation processes and templates
- Support implementation of electronic validation systems (e.g., Kneat, Veeva)
- Drive standardization across sites
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
- Experience with manufacturing and laboratory systems validation
- 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
- Experience with facility startup and commissioning
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