Computer System Validation Specialist

6 days ago

Singapore beBeeValidator Full time

About the Role

We are seeking a skilled Computer System Validation specialist to play a critical role in supporting projects on site with clients.

Key Responsibilities:

  • 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.

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