Process Engineering & Validation Expert 4

This position is responsible for executing computer system validation projects. Computer System Validation Consultant will be a member of the validation team developing, reviewing, executing, and managing validation activities, and ensuring that the validation activities are consistent with user’s / manufacturer’s requirements and site quality standards. This role will be responsible for validation activities such as :

• Assist with CSV validation projects for and manage project schedule.
• Author and review validation documents, URSs, plans and SOPs.
• Perform impact and risk assessments / FMEAs for systems.
• Interact with cross-functional groups ensuring effective communication.
• Work with computer system vendors to define requirements and understand functional specifications.
• Support site for data integrity and CSV assessments for GMP critical systems.