Validation Engineer II - CSV and Compliance Report

Need aValidation Engineer II - CSV and Compliance Report at Hillsboro, OR 10+

NO H1b if need 1988 below DOB

Long term contract

Onsite/Hybrid

Description:

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 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

Primary skill set:

Minimum Requirements:

Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
Minimum 9 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
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 is required. 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.