Biotech CQV Expert

3 days ago

Dublin, Dublin City, Ireland beBeeBiotech Full time €55,000 - €65,500
Senior Biotech Commissioning and Qualification Engineer

We are seeking an experienced Senior Biotech Commissioning and Qualification Engineer to lead our team in Dublin, Ireland.

  • Owning projects, equipment, responsible for document drafting and protocol execution
  • Completing all qualification training and getting up to speed with Standard Operating Procedures (SOPs)
  • Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects
  • Ensuring C&Q activities associated with various capital projects are completed safely, on schedule, and in compliance with Good Manufacturing Practices (GMP) and Quality Requirements

Key Responsibilities:

  • Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation
  • Generating, reviewing, and executing documents for both the company and vendors
  • Collaborating closely with system owners, Quality Assurance, and other stakeholders
  • Providing technical assistance during investigations and system design
  • Coordinating and supervising all C&Q activities on their systems
  • Ensuring the C&Q schedule is maintained
  • Managing Daily C&Q coordination meetings
  • Responsible for tracking and reporting of C&Q status and risks/issues
  • Ensuring startup of equipment/utilities is completed in a safe and coordinated manner
Requirements

We require candidates with the following qualifications and experience:

  • 6+ years of experience in Engineering or Commissioning and Qualification Management
  • Technical qualification at third level or equivalent in Engineering
  • Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred
  • Knowledge of safety, GMP, and environmental regulatory requirements
  • Demonstrated strong Communication and Leadership skills
  • Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
  • Familiarity with paperless validation systems
Package

This contract role offers:

  • Hourly rate €55 - €65 per hour
  • Minimum 12 month contract with the possibility of extension
  • At least three days per week onsite expectation

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