Nesco Resource · 13 hours ago
Validation Engineer II - (Biotech/Biomedical)
Hillsboro, OR
Full-time
Onsite
Senior Level
$70/hr - $75/hr
5+ years expNesco Resource is a staffing company seeking a Validation Engineer II for a contract position in the biotech/bioengineering domain. The role involves supporting ITOT system owners with computer system lifecycle tasks, including validation, documentation, and testing, while ensuring compliance with GMP standards.
ConsultingHuman ResourcesStaffing Agency
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, Client, 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 Roche)
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: 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
Benefits
MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Company
Nesco Resource
Nesco Resource s an Staffing and Recruiting firm.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Michael McDonald
Executive Vice President of Finance and Chief Accounting Officer
Recent News
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2023-12-24
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2023-12-24
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