Computer System Validation
3+ month contract with potential for extension
Sponsorship is not available for this role now or in the future
Our client is currently seeking an experienced Computer System Validation Engineer with some project management experience and a minimum of 5 years of life sciences experience .
Job Description:
·Responsible for development, execution & analysis of validation projects to demonstrate computer system cGMP compliance.
·Author IV/OV and IQ/OQ Protocols
·Document and Test systems I/O
·Document and Test User Log on and System Security
·Document and Test Alarms and Messages
·Document and Test Interlocks/Safety
·Document and Test Process/Sequential Control
·Document and Test Recipe Management – N/A
·Document and Test Reports
·Document and Test HMI Screens/Navigation
·Document and Test Trending: Real-Time & Historical
·Document and Test Numerical Calculations
·Document and Test restart and Recovery
·Document and Test Redundancy or Hot Back-up Scenarios
·Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure and optimization of validation approaches.
Qualifications:
·A Bachelor’s or Masters of science degree in Pharmacy, Engineering or Science is required.
·3+ years of experience in life sciences engineering is required.
·1+ years of experience in validation is required.
·Experience working in FDA/cGMP compliant environment required.
·Strong collaboration, communication, and presentation skills required.
·Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
Experience with PAS-x strongly desired.
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