Senior Validation and Verification Specialist

Responsibilities

Validation Lifecycle Leadership

• Author, review, and execute validation lifecycle documentation (VP, URS, FS, DS, IQ/OQ/PQ, Summary Reports)
• Develop and maintain Requirements Traceability Matrices (RTM) and Risk Assessments
• Lead validation activities for clinical, manufacturing, laboratory, and quality systems

Compliance & Quality Assurance

• Ensure strict adherence to FDA 21 CFR Part 11, EU Annex 11, GxP, and GAMP 5 principles
• Apply risk-based validation approaches per GAMP 5 categorization
• Perform gap assessments and develop remediation plans for legacy systems

Audit & Regulatory Support

• Support client audits (internal, vendor, regulatory inspections)
• Prepare validation evidence packages for regulatory submissions (FDA, EMA, MHRA)
• Respond to FDA 483 observations and CAPA implementations related to CSV

Collaboration & Knowledge Sharing

• Collaborate across time zones with global project teams and client stakeholders
• Mentor junior validation engineers on CSV best practices
• Contribute to Infiligences validation methodology and knowledge base

What You Bring

Required Qualifications

• Bachelors degree in Engineering, Life Sciences, Computer Science, or related field
• 7+ years of hands-on CSV experience in life sciences/pharmaceutical environments
• Deep expertise in validation lifecycle (V-Model, Agile Validation)
• Strong working knowledge of FDA 21 CFR Part 11, EU GxP, GAMP 5 (v5 categories), and Annex 11
• Experience validating systems such as: LIMS, ERP (SAP, Oracle), MES, SCADA, QMS, EDC, CTMS, or EHR/EMR platforms
• Proficiency in creating validation documentation per global standards

Preferred Qualifications

• Experience with CSV for cloud-based systems (AWS, Azure, Veeva, Salesforce)
• Familiarity with data integrity (ALCOA+) principles
• Knowledge of electronic signatures and audit trail requirements
• Exposure to automated testing tools for validation (Selenium, TestComplete)
• Prior experience supporting FDA/EMA/MHRA inspections
• Certifications: ASQ (CSQE, CQE), RAPS, or ISPE GAMP certification

Essential Skills

• Excellent technical writing and documentation skills
• Strong analytical and problem-solving abilities
• Detail-oriented with exceptional organizational skills
• Effective communication with technical and non-technical stakeholders
• Ability to work independently and manage multiple priorities
• Flexibility for occasional overlap with US/Canada time zones

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