QC Validation Engineer Laboratories

Description

Role - QC Validation Engineer Laboratories
Type - initially 12 month contract
Location - Co. Limerick

Summary
One of our key clients in Ireland is looking for an experienced individual in laboratory equipment validation to complete tasks required for the equipment qualification for the QC Laboratory in a multiproduct Biotech facility. The Quality/Validation subject matter expert (SME) will be responsible to provide guidance on validation and testing strategies for client projects.

Key Responsibilities:
• Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria for the QC Laboratory.
• May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
• Manages projects and prepares status reports.
• May trains/advise less experienced Specialists and Technicians.
• Co-ordinates prioritisation of activities with area management.
• Ability to design and develop validation strategies and plans.
• Maintain validation related metrics and reports performance to management.
• Writing and executing equipment qualification protocols and subsequent summary reports.
• Execution of controlled temperature unit qualifications through the following:
• Analysis and review of validation data to be compiled for validation summary reports.
• Troubleshoot issues encountered during qualification and ensure timely reporting of deviations.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Reviews, edits and approves change control and SOPs.
• Collaborates with functional departments to resolve issues.
• Assesses quality system documentation for completeness and accuracy, and dispositions documentation within the company’s SOPs.
• Partner with the application owners and system implementation teams to ensure CFR Part 11 Compliance

Key Requirements:
• Significant recent project based experience in the commissioning and qualification of laboratory equipment
• Expertise and knowledge on project based risk, complexity and other relevant factors are required within regulated industries.
• Strong background within the biotechnology or pharmaceutical industry.
• Proactive, “hands on” mentality, able to hit the ground running and work independently.
• Experience writing and executing validation documentation in the biopharmaceutical industry.
• A practical working knowledge of validation, quality assurance, information systems, and risk management best practices.
• Knowledge of GxP (GCP preferred) and CFR Part 11. Must be well organized and willing to work as part of a team.
• Excellent communication, interpersonal skills, and customer focus.