CQV Engineer – Clean Utilities

1 day ago


Dublin, Dublin City, Ireland Recruitment by Aphex Full time

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Senior Recruitment Consultant at Recruitment By Aphex

Purpose

Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Owns projects, equipment, responsible for document drafting and protocol execution.

Responsibilities

  • Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation.
  • Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report).
  • Provide technical assistance during investigations and system design.
  • Coordinates and Supervises all C&Q activities on their systems.
  • Ensures the C&Q schedule is maintained.
  • Manages Daily C&Q coordination meetings.
  • Responsible for Tracking and Reporting of C&Q status and risks/issues.
  • Ensures 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).

Qualifications

  • 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.
  • 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.
Seniority level

Mid-Senior level

Employment type

Contract

Job function

Pharmaceutical Manufacturing

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