Validation Consultant
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Our client, a leading biotechnology organization, is seeking a Validation Consultant to support their electronic compliance team and computer systems lifecycle management. This role focuses on ensuring that IT quality processes and validation activities are aligned with international regulatory standards and risk-based principles.
Responsibilities
- Lead the authoring, review, and approval of validation and qualification deliverables within an electronic document management system.
- Drive the consistent application of GAMP 5 and risk-based validation principles across the project.
- Provide validation oversight to ensure deliverables are complete, consistent, and compliant with industry standards.
- Identify, assess, and manage validation risks and quality events including change controls, deviations, and CAPAs.
- Contribute to the continuous improvement of validation and qualification SOPs, standards, and templates.
- Provide CSA and CSV subject‑matter expertise to project teams to resolve complex compliance issues.
- Oversee the successful completion of release management for various digital platforms and solutions.
Requirements
- Bachelor’s or Master’s degree in Computer Science, Life Sciences, or Engineering.
- You have 5+ years of hands‑on experience in CSV and CSA within a regulated industry such as pharma or biotech.
- You bring extensive knowledge of GxP computerized‑system lifecycle management, including validation planning, risk assessment, and data integrity.
- You possess technical experience with cloud data warehouses like Snowflake or Databricks and visualization tools such as Tableau or Power BI.
- You have deep familiarity with AI governance frameworks and the validation of complex systems like Generative AI and LLMs.
- You're able to communicate and influence across multidisciplinary teams while providing pragmatic solutions in regulated environments.
- You are fluent in English.
Nice to Haves
- Experience with enterprise platforms such as Veeva, ERP, Jira, ServiceNow, and IAM technologies.
- Experience with data platforms, analytics qualification, and related framework assessments.
- Prior experience with the validation of computerized systems leveraging AI functionalities in a regulated environment.
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