Validation Engineer - CSV and Compliance Support

Validation Engineer - CSV and Compliance Support ROCGJP00039357

• Hourly pay: $60-$70/hr
• Worksite: Leading biotechnology company (Hillsboro, OR 97124 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 12 Month Assignment

A leading biotechnology company is seeking a Validation Engineer - CSV and Compliance Support. The successful candidate will support the ITOT System owners in tasks associated with the lifecycle of computer system, ie. maintenance, validation, documentation, and testing.

Validation Engineer - CSV and Compliance Support Responsibilities:

• Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, BAS). Systems will fall between Level 2 and 3 of the ISA-95 model
• Help perform (annual system maintenance) activities for ITOT Systems.
• Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.
• Perform system periodic review.
• 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 protocol.
• Collaborate with local and global stakeholders in defining and completing validation and compliance activities.

Validation Engineer - CSV and Compliance Support Qualifications

• 5 years of experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
• Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
• 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.
• Good understanding of the ISA-95 model.
• Experience working with Level 2 and Level 3 systems.
• Experience working with Level 1 systems is a plus.
• 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.

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