Estuate, Inc. · 22 hours ago
Validation Engineer II - CSV
Hillsboro, OR
Contract
Onsite
Senior Level
5+ years expEstuate, Inc. is seeking a Validation Engineer II - CSV to support the ITOT System owners in the lifecycle management of computer systems. The role involves creating and updating validation documentation, performing maintenance activities, and ensuring compliance with GMP regulations.
Information Technology
Hiring Manager
Pradeep Mohan
Responsibilities
Work to support the ITOT System owners in tasks associated with the lifecycle of computer system, ie. maintenance, validation, documentation, testing
Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model
Help perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc
Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed
Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports
Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems
Support validation activities, generation, approval and execution of validation protocols
Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance
Support on documents management systems (Veeva, Condor, eVal)
Support the team with administrative tasks, such as document formatting, document routing
Collaborate with local and global stakeholders in defining and completing validation and compliance activities
Attend Quality Huddle Meetings
Provide Quality Metrics
Align with global Validation protocols and policies
Qualification
Required
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field
Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry
Good understanding of the ISA-95 model
Experience working with Level 2 and Level 3 systems is required
Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles
Good understanding of system and data integrity risk assessment concepts
Preferred
Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development
Experience working with Level 1 systems is a plus
Company
Estuate, Inc.
We at Estuate help you thrive with our out-of-the-box tech solutions.
201-500 employees
H1B Sponsorship
Estuate, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (18)
2023 (8)
2022 (16)
2021 (12)
2020 (22)
Funding
Current Stage
Growth StageLeadership Team
P
Prakash Balebail
Founder and CEO
Nagaraja Kini
Co-Founder, CFO
Company data provided by crunchbase