Senior Biotechnology Commissioning Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeCleanUtility Full time €5,500 - €6,500

Biotech CQV Engineer Opportunity

About the Job:

We are seeking a skilled Biotech CQV Engineer to join our team. The successful candidate will be responsible for owning projects, equipment, and document drafting while ensuring qualification activities are completed safely and in compliance with GMP and quality requirements.

Key Responsibilities:

  • Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects
  • Ensure C&Q activities associated with various capital projects are completed safely, as per schedule, and in compliance with GMP and Quality Requirements
  • Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation
  • Generate all C&Q test documents
  • Provide technical assistance during investigations and system design
  • Coordinate and Supervise all C&Q activities on their systems
  • Manage Daily C&Q coordination meetings
  • Track and Report of C&Q status and risks/issues
  • Ensure Startup of equipment/utilities is completed in a safe and coordinated manner
  • Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

Requirements:

  • 6+ years 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
  • Demonstrated strong Communication and Leadership skills
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
  • Familiarity with paperless validation systems
  • Experience in commissioning and qualification of process equipment and or Utilities

About the Role:

This is an excellent opportunity to work in Ireland's leading aseptic manufacturing plant. Our client is a leading international Biotechnology company with a state-of-the-art aseptic manufacturing facility.

Package:

Contract role - Hourly rate €55 - €65 per hour

Minimum 12-month contract with the possibility of an extension

At least three days per week is the onsite expectation

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