IT Validation Specialist (12 months)
Key Responsibilities
Validation Strategy & Compliance
- Develop and execute risk-based validation strategies for GxP-regulated systems
- Ensure compliance with CSV, CSA, Data Integrity, FDA 21 CFR Part 11 and EU GMP Annex 11 requirements
- Provide expert validation guidance during audits, inspections and quality assessments
- Drive standardisation and continuous improvement of validation practices
System & Automation Validation
- Lead validation activities for system implementations, upgrades and integrations
- Perform impact assessments and validation risk assessments
- Review requirements, system designs, configurations and functional specifications
- Support validation of both IT and automation/OT solutions
- Ensure validation requirements are incorporated into project delivery plans
Documentation & Lifecycle Management
- Author and review validation documentation including:
- Validation Plans
- Risk Assessments
- IQ/OQ/PQ Protocols
- Traceability Matrices
- Validation Summary Reports
- Maintain inspection-ready documentation throughout the system lifecycle
Quality & Governance
- Support change control, deviations, CAPA activities and investigations
- Ensure validation activities align with quality and regulatory expectations
- Promote risk-based decision making within project teams
Stakeholder Management
- Collaborate with Quality, Manufacturing, Engineering and IT teams
- Provide mentoring and guidance on CSV/CSA best practices
- Coordinate validation activities with external vendors and implementation partners
Required Experience
- Bachelor's degree in Engineering, IT, Computer Science, Life Sciences or a related discipline
- 8+ years of CSV, CSA or Validation Engineering experience
- Strong expertise in validation risk assessments and validation lifecycle management
- Experience validating automated systems within GMP-regulated environments
- Knowledge of:
- GAMP 5
- CSA principles
- FDA 21 CFR Part 11
- EU GMP Annex 11
- Data Integrity requirements
- Experience supporting audits and regulatory inspections
- Excellent stakeholder engagement and communication skills
Desirable Experience
- SAP validation
- MasterControl
- MES
- LIMS
- QMS platforms
- OT validation
- Digital transformation projects
- Validation certifications
Ideal Candidate Profile
FAQs
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