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System Validation Technical Lead
3 weeks ago
About the Role
We are seeking a skilled Computer System Validation Specialist to play a critical role in supporting projects on site with clients.
- System Design and Development: Design, develop, and execute system validation strategies for DeltaV systems, ensuring alignment with regulatory requirements and project timelines.
- Collaboration and Communication: Collaborate with cross-functional teams (engineering, QA, IT, etc.) to define system requirements, assess functionality, and develop robust validation plans.
- Validation Activities: Conduct and oversee validation activities including IQ, OQ, and PQ to ensure systems meet compliance, performance, and reliability standards.
- Risk Assessment and Mitigation: Perform risk assessments and impact analyses to proactively identify potential gaps, and implement appropriate mitigation strategies.
- Documentation and Compliance: Prepare and maintain comprehensive validation documentation such as plans, protocols, reports, and SOPs, in line with internal standards and regulatory guidelines.
- Technical Expertise: Provide leadership and hands-on support throughout system configuration, testing, documentation review, and deviation management.
- Troubleshooting and Continuous Improvement: Offer technical expertise in troubleshooting CSV-related issues and ensure timely resolution and continuous improvement.
- Staying Up-to-Date: Keep up-to-date with evolving regulatory requirements, industry standards, and innovations related to CSV and DeltaV technologies.
- Audit and Inspection Support: Act as the point of contact during audits and inspections, presenting documentation and validation rationale to auditors and regulatory bodies.
What's in it for You?
We offer a range of benefits, including travel opportunities, medical coverage, annual leave options, and training and development allowance. You'll also have the chance to work with world-class teams delivering high-end projects for global businesses.
About Us
We operate as an equal opportunity employer, committed to diversity and inclusion. We welcome applications from individuals with diverse backgrounds and skills.