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.