R&D Partners · 23 hours ago
Validation Engineer - CSV and Compliance Support
Portland, OR
Full-time
Onsite
Entry, Mid Level
$74/hr - $94/hrR&D Partners is seeking a Validation Engineer focusing on CSV and Compliance to support the lifecycle management of computer systems used in pharmaceutical operations. The role involves ensuring compliance, performing maintenance, and creating necessary documentation for validation and system integrity.
Human ResourcesStaffing Agency
No H1B
Hiring Manager
Jack Keens
Responsibilities
Assist system owners with tasks related to maintaining and validating computer systems
Create and update documentation for system validation and lifecycle support
Perform annual system maintenance activities, including creating and reviewing test protocols
Manage quality records such as CAPAs, deviations, and planned events, ensuring timely completion
Conduct periodic system reviews by analyzing past events and assessing their impact on system validation
Support system procurement, development, integration, operation, and retirement processes
Help with system upgrades, patches, and changes to maintain compliance
Generate reports and assist with administrative tasks like document formatting and routing
Collaborate with global and local teams to align with validation protocols and policies
Attend quality meetings and provide metrics to ensure compliance
Qualification
Required
Background in computer science, engineering, life sciences, or a related field
Familiarity with computer system validation frameworks (CSV/CSA) and GAMP principles
Knowledge of systems like SCADA, OSI-PI, DeltaV, MES, and other manufacturing execution tools
Understanding of regulatory guidelines such as FDA 21 CFR Part 11, EU GMP Annex 1, and data integrity principles
Experience with system administration, recipe authoring, and risk assessment concepts
Strong organizational and communication skills to collaborate with diverse stakeholders
Applicants must have legal authorization to work in the United States
Company
R&D Partners
R&D Partners is a national staffing agency that specializes in scientific, clinical, and engineering positions.
Founded in 2007
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
Company data provided by crunchbase