Validation Engineer
Menlo Park, CA
Support Ops /
Permanent /
Remote
A Day in the Life of our Validation Engineer
We are seeking a highly skilled and detail-oriented Information Technology Validation Engineer to join our team. As a Validation Engineer, you will play a critical role in validating software, hardware, and IT infrastructure to ensure their reliability, security, and compliance with applicable regulations.
Who Should Apply
The ideal candidate will have a strong background in IT systems validation, ensuring that our information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good Manufacturing Practice, Good Laboratory Practice, or Good Clinical Practice).
Daily Responsibilities
- Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for IT systems, software, and infrastructure, ensuring compliance with GxP regulations
- Collaborate with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Operations, to ensure validation activities are aligned with project timelines and GxP requirements
- Perform risk assessments specific to GxP guidelines to identify potential vulnerabilities in IT systems and develop mitigation strategies to address them
- Conduct periodic reviews and audits of IT systems to ensure ongoing compliance with GxP regulations and other relevant guidelines
- Document validation activities, including test plans, protocols, reports, and deviations, in accordance with company procedures and GxP requirements
- Participate in change control activities by assessing the impact of proposed changes to IT systems and ensuring appropriate validation documentation is updated in compliance with GxP regulations
- Provide support during regulatory inspections and audits by presenting validation documentation and responding to inquiries related to GxP compliance
- Participate in Project planning and Project Management activities to ensure timelines and deliverables are achievable and met
- Stay current with industry trends, best practices, and regulatory requirements related to GxP and IT system validation, and make recommendations for process improvements
Qualifications and Skills
- Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field. Advanced degree preferred
- Minimum of 5 years of experience in IT system validation within the pharmaceutical, biotechnology, or medical device industry, with a strong emphasis on GxP compliance
- Strong understanding of regulatory requirements governing IT systems in GxP environments, including FDA regulations, GAMP 5, Annex 11, and other relevant guidelines
- Experience developing and executing validation protocols for IT systems, software, and infrastructure in accordance with GxP regulations
- Knowledge of risk assessment methodologies specific to GxP guidelines and experience applying them to IT validation activities
- Excellent documentation and communication skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.
- Strong analytical and problem-solving skills, with meticulous attention to detail in ensuring GxP compliance
- Ability to work both independently and collaboratively in a fast-paced environment within a GxP-regulated industry
- Strong project management experience with the ability to develop project schedules aligning with both end user and management expectations for deliverables and timelines
- Strong understanding of use of Jira, Confluence, and XRay for Validation and deliverable execution
- Understanding of Veeva for Validation deliverable storage and maintenance desirable
$100,000 - $150,000 a year
