Computer System Validation Engineer (Completely Remote)

Duration: 6+ Months

Job Description:

Roles and Responsibilities:

• The validation engineer will support computer system validation initiatives for the client.
• Develop system validation scripts based on software/hardware configuration for enterprise systems
• Work with facility Subject Matter Experts to document user requirements
• Update application system User Requirements, Functional, and Design Specifications
• Develop Installation Qualifications based on Design
• Develop Operation Qualifications based on functional requirements
• Develop Performance Qualification scripts based on configuration
• Perform test execution or lead execution activity
• Route validation documentation
• Manage Tasks based on aggressive timelines
• Interact with customers at multiple sites
• Interact in team environment

Required Qualifications:

• Validation experience with enterprise computer systems (ERP, LIMS, QMS, ECM, LMS, etc) in the pharmaceutical industry.
• Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation.
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
• Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Strong technical background
• Strong communication and interpersonal skills ensuring the ability to interact with the business, peers, and vendors in a professional manner.
• Ability to work independently with minimal supervision and adhere to timelines.
• Experience with SDC/validation or Middleware/validation. (preferred but not required)
• University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.