Sr Computer System Validation Engineer
Sr Computer System Validation Engineer
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1 Vacancy
Job Description
- Develop and implement validation plans for computer systems in compliance with regulatory requirements.
- Conduct risk assessments to identify potential issues in computer processes and implement corrective actions.
- Create review and approve protocols for validation testing including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ).
- Oversee the of validation activities ensuring adherence to established protocols and timelines.
- Document validation processes and results clearly and comprehensively for audit purposes.
- Collaborate with IT Quality Assurance and other departments to facilitate cross-functional support and knowledge sharing.
- Provide guidance and training to junior engineers on validation methodologies and best practices.
- Monitor and evaluate existing systems and recommend improvements to enhance efficiency and compliance.
- Participate in internal and external audits providing expertise and documentation to support validation efforts.
- Maintain up-to-date knowledge of industry standards regulations and best practices related to computer system validation.
- Prepare reports on validation status issues and risk assessments for management review.
- Support the development and implementation of Standard Operating Procedures (SOPs) for validation processes.
- Lead projects that involve the validation of new systems or software being introduced to the organization.
- Act as a subject matter expert during project meetings clarifying validation needs and expectations.
- Ensure the integration of quality management principles into the validation process.
- Bachelors degree in Computer Science Engineering Life Sciences or a related field.
- A minimum of 5 years of experience in Computer System Validation within a regulated industry.
- In-depth knowledge of FDA regulations and GxP practices.
- Professional certification in quality management or validation (e.g. CQE CQA) is preferred.
- Experience with validation of laboratory and manufacturing systems.
- Strong understanding of IT systems software development life cycles and computer system validation methodologies.
- Proficiency in developing and executing validation documentation.
- Excellent verbal and written communication skills with the ability to convey complex technical concepts.
- Demonstrated ability to manage multiple projects and prioritize effectively.
- Strong attention to detail and analytical thinking capabilities.
- Previous experience in leading validation projects or teams is highly advantageous.
- Ability to work collaboratively with cross-functional teams and influence stakeholders.
- Familiarity with statistical software and data analysis tools.
- Proficient in Microsoft Office Suite (Word Excel PowerPoint).
- Ability to adapt to changes in regulatory standards and technology.
- Willingness to travel occasionally for audits and project meetings if required.
team collaboration,regulatory compliance,process improvement,data analysis,project management,technical documentation,quality management,computer system validation,risk management,data analysis tools,documentation,risk assessment,validation protocol development,statistical software,problem solving,microsoft office suite,cross-functional collaboration,quality assurance
Employment Type
Full Time
