Job ID: JOB_ID_419
Role Overview: CSV Validation Engineer II
Healthcare Triangle is seeking a highly skilled Validation Engineer II specializing in Computer System Validation (CSV) and Compliance Reporting for a long-term contract engagement in Hillsboro, OR. This role is critical in supporting ITOT (Information Technology / Operational Technology) system owners throughout the entire lifecycle of computer systems, ensuring that all maintenance, validation, documentation, and testing activities meet stringent regulatory standards.
Key Responsibilities and Duties
- Support ITOT System owners in tasks associated with the lifecycle of computer systems, including maintenance, validation, documentation, and testing.
- Create and update Computer System Validation (CSV) and lifecycle support documentation for various ITOT systems such as DeltaV, PI, MES, SCADA, LyoPlus, FIT, BAS, and WAGIT.
- Manage systems falling between Level 2 and 3 of the ISA-95 model, ensuring seamless integration and compliance.
- Perform MILE (annual system maintenance) activities, including the creation, update, execution, and review of installation and test protocols.
- Own and manage Quality Management System (QMS) records, including CAPA (Corrective and Preventive Actions), Planned Events, and Deviations.
- Orchestrate the completion of activities required to resolve quality records and maintain system integrity.
- Perform system periodic reviews by collecting data from deviation databases over a three-year period to assess the impact on the validated state.
- Draft comprehensive reports based on periodic reviews and data collection.
- Support the System Owner squad in procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
- Generate, approve, and execute validation protocols to support ongoing validation activities.
- Assist System Owners in maintenance tasks such as Periodic System Audit Trail Reviews and account audits.
- Create on-demand reports for various systems to support business needs and regulatory inquiries.
- Collaborate with System Owners and Business Process Owners for system upgrades, patching, and changes to ensure continuous GMP compliance.
- Utilize document management systems such as Veeva, Condor, and eVal Roche for routing and formatting.
- Provide Quality Metrics and attend Quality Huddle Meetings to align with global validation protocols and policies.
Technical Requirements and Qualifications
- Bachelor of Science or equivalent in Computer Science, Engineering, Life Sciences, or a related technical field.
- Minimum of 5 years of experience in Computer Systems Validation frameworks (CSV/CSA, GAMP 5).
- Extensive experience within the Pharmaceutical or Life Sciences industry is highly preferred.
- Technical proficiency in SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, and DeltaV.
- Experience with Manufacturing Execution Systems (MES) administration and EBR (Electronic Batch Record) recipe authoring.
- Strong understanding of the ISA-95 model, specifically working with Level 2 and Level 3 systems.
- In-depth knowledge of FDA regulations including 21 CFR Part 11, Annex 11, EU GMP Annex 1, and GxP practices.
- Solid understanding of Data Integrity principles and risk assessment concepts.
- Excellent communication skills to collaborate with local and global stakeholders.
Special Requirements
Long-term Contract; Domain: Pharma/Life Sciences; Systems: ITOT/ISA-95; Tools: Veeva, DeltaV, OSI-PI.
Compensation & Location
Salary: $75 – $105 per year (Estimated)
Location: Hillsboro, OR
Recruiter / Company – Contact Information
Recruiter / Employer: Healthcare Triangle
Email: subash.k@securekloud.com
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