Description

You will lead and manage Computer System Validation (CSV) to ensure all computer and instrument systems remain compliant with industry standards and regulatory guidance.

Responsibilities

• Manage CSV and Computer System Change Control processes using risk-based methodologies.
• Conduct GxP evaluations for new computer and instrument systems, including cloud-based solutions and SaaS tools.
• Review and approve CSV lifecycle documentation, system-specific administration SOPs, and user access reviews.
• Oversee formal test execution and vendor qualification documentation to ensure compliance.
• Act as the QA CSV Subject Matter Expert during audits and regulatory reviews.

Required Skills

• 10+ years of experience in electronic-based Computer System Validation within a GxP environment.
• Proven experience validating cloud-based computer solutions and GxP SaaS tools.
• Deep knowledge of the full software development life cycle (SDLC).
• Expertise in authoring, reviewing, and executing validation documents and test scripts.
• Hands-on experience with eDMMS tools such as Documentum or Master Control.
• Proficiency with testing tools including Jira and ALM.
• Experience qualifying GLP Instrument Systems.
• Strong project management experience for regulatory projects.
• Bachelor's degree or equivalent formal academic qualification.

Preferred Skills

• Experience with ValGenesis, Kneat, TX3, or First Doc.
• Knowledge of GAMP and CAPA processes.

Key Skills

Education

Bachelor's degree