Engineering Validation Associate (Biotech)

Engineering Validation Associate required for a leading Biotech facility in Ringaskiddy, Cork, reports to the Commissioning Qualification and Validation Manager, day to day technical direction may be delegated to the Engineering Validation Team Lead as required, and is responsible for fulfilling validation activities in a GxP regulated environment, including implementation of laboratory systems, new manufacturing equipment/processes and changes to existing equipment/processes. Initially a 12 month contract.

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• In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programs.
  
• Execute (protocol generation, execution, and final package preparation) Validation activities related to the various Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control.
  
• Develop validation plans for specific system implementation projects.
  
• Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
  
• Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
  
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
  
• Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
  
• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured, validation techniques/approaches and systems utilized.
  
• Lead and represent validation in multi-departmental meetings and project teams.
  
• Identifies and implements improvements to the Engineering Validation systems.
  
• Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
  

Other duties as assigned. xcfaprz

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• B.Sc. in Engineering, Science
  
• Minimum 3+ years' similar experience in Engineering Validation
  
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
  

Skills: Engineering Validation Associate Validation Biotech