Engineer Validation

• Prepare validation/qualification lifecycle deliverables such as Validation Plans, Requirements Specifications, Traceability Matrix, Summary Reports, Change Controls.
• Ensure that the equipments are manufactured and following CE complaint/CE marked directives
• Prepare, review and execute qualification/ validation protocols and associated reports while adhering to a regulatory requirement.
• Develops written procedures for operation and maintenance of equipment.
• Manages Validation deliverables for projects of varying scope and complexity.
• Manages all lifecycle deliverables in the Validation of equipment and single / multi-user Computerized Systems.
• Assist in development of Validation practices, procedures in adherence with pharma standards.
• Maintains a positive relationship with all project team members, other departments and site customers while promoting a positive team

Qualification And Experience:-

• Engineering Graduate (Chemical Engineering - preferred)
• 3 - 5  years of Validation experience in FDA-regulated industry.
• Excellent understanding of cGMP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Should have worked on Validation documentation based on current GAMP, 21 CFR Part 11, EU and FDA regulations, CE directives
• Should have effectively manage multiple tasks and activities simultaneously.
• Experience executing equipment qualification documents.
• Experience with technical writing and document development / generation.
• Strong computer skills in Microsoft Office Application – Word, Excel, and Power point, and the ability to learn new software as required for validation.

Location:-

• Vadodara, Gujarat.

Company Overview:-

GEA is one of the largest technology suppliers for food processing and a wide range of other industries. The global group specializes in machinery, plants, as well as process technology and components.
GEA provides sustainable solutions for sophisticated production processes in diverse end-user markets and offers a comprehensive service portfolio.