Computer System Validation Engineer

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Job description

Computer System Validation Engineer

3+ month contract role with potential for extension

Location: Melrose Park, IL

Onsite

Sponsorship is not available for this role now or in the future

Automated Systems, Inc. is currently seeking an experienced Computer System Validation Engineer with some project management experience and a minimum of 5 years of life sciences experience for one of our clients in Melrose Park, IL.

Job Role 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.

Education and Experience 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)

Experience with PAS-x strongly desired.

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