R&D Partners · 19 hours ago
Validation Engineer (Computer System Validation)
Hillsboro, OR
Contract
Onsite
Senior Level
$157K/yr - $196K/yr
5+ years expR&D Partners is a global functional service provider specializing in scientific, clinical research, and engineering. They are seeking a Validation Engineer to support validation activities within a GMP biotechnology environment, partnering closely with IT/OT system owners to manage the lifecycle of computer systems.
Staffing Agency
Responsibilities
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)
Support the team with administrative tasks, such as document formatting, document routing
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
Benefits
Medical insurance – PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
Company
R&D Partners
R&D Partners is a national staffing agency that specializes in scientific, clinical, and engineering positions.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-06-01Acquired
Leadership Team
Pooja Pathak
R&D Partners Research Scientist at Bristol Myers Squibb
Scott Hopkins
Founder and Member of Board of Directors
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