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CQV Engineer

  1. Midlands (Ireland)
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
06-12-2023
32605
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Junior-Mid Level CQV Engineer - Carlow - 11-Month Contract+

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Junior - Mid Level CQV Engineer to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. 


Role Summary:
  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as C&Q SME on the equipment within the area assigned. 
  • As such you will be executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
  • Technical owner of Commissioning protocols, Qualification protocols and input to Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
 

Requirements:
  • This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
  • SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities - Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1
  • Experience with liaising with other departments – engineering, technical, operations and QA
  • Experience with sterile processing and sterilisation technologies
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  • Autoclave Qualification and Sterilisation Loads Cycle Development experience.
  • Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing, and interpreting complex data

If this role is of interest to you, please apply now!




The candidate must have the rights to work in the location stated in the job advert.

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