Lab Equipment Validation Scientist

Pe Global

Kildare

PE Global are currently recruiting for a Lab Systems Validation Scientist in Kildare - Job Title: Laboratory Validation Scientist/Engineer. Job Purpose: We are seeking a Lab system Validation Scientist/Engineer to work with with Quality Laboratories and Business Technology (I.T) functions. The primary aim is to upgrade and validate a number of key analytical computerised systems. The Lab Validation Scientist/Engineer will be required to project manage and complete validation efforts for computerised laboratory systems, in accordance with regulatory requirements and company quality standards. Job Responsibilities: Generate, execute and complete validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Ensure all aspects of Computer/Laboratory Validation adhere to required policies and procedures, including safety and training. Drive execution of validation efforts, coordinating with above site resources and site SMEs. Prepare and execute validation documentation according to approved protocols and SOPs. Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. Provide expertise for trouble shooting and resolution of problems which may occur. Generate, review and approve validation deviations and ensures successful implementation of corrective actions. Assist in the raising and execution of change controls. Coordinates with other departments or outside contractors/vendors to complete validation tasks. Manages projects and prepares status reports. Experience: A minimum of 5 Years cGMP industrial experience, ideally performing Equipment/Computer/Laboratory system Validation. Validation experience is ESSENTIAL. Experience working with automated control systems advantageous. Experience of FDA and EU licensing and inspection. Demonstrated aptitude for technical learning and problem solving. Education: Minimum qualification of a B. Sc. Degree in Engineering, Bioprocess Science, Biotechnology or equivalent with particular emphasis in Biochemical, Chemical or Mechanical discipline. Interested candidates should send their CV for the attention of Audrey Brennan to audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2262 days ago