Computer System Validation Engineer - Georgia, Atlanta

The announced job offer is made public by the firm: Germer International - Pharmaceutical Recruiting and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Georgia at the city Atlanta, in the country US - at this current ZipCode: 30301

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Our client is looking for a Computer System Validation (CSV) Engineer. This role will focus on providing a technically competent risk based approach for the validation of computer systems. You will be a project team member and have responsibility for identifying and communicating validation tasks, resource requirements and task durations for significant cross-functional projects.

As the CSV Engineer you will be responsible for creation, review, execution, and approval of validation protocols, reports and other relevant documentation.

This role is a hybrid role with approximately 70% remote and 30% on site.

Responsibilities:

• Planning and execution of significant cross-functional validation projects mainly in support of computer system validation
• Write and review protocols and reports. Review and/or approval of change control
• Perform and lead risk assessment exercises in support of validation activities and perform periodic reviews as needed
• Coordinate validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects
• Review and update validation SOPs
• Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, utilities, facilities, product, process, computer system and cleaning validation
• Validation representative on site project team and resource to other departments for product and process knowledge

Requirements:

• Bachelor's degree in Engineering
• 5+ years relevant experience in pharmaceutical industry with validation experience
• Demonstrated validation proficiency with knowledge consistent of an SME in one or more of the areas of validation: equipment qualification, critical utilities and facilities qualification, cleaning validation, process validation, or computer/automation systems validation
• Experience leading technical projects and effectively handling multiple ongoing projects