CQV Engineer – Clean Utilities

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  • Job type

    Temporary

  • Location

    Dublin City

  • Working Pattern

    Full-time

  • Specialism

    Quality Assurance

  • Industry

    Pharmaceuticals

  • Pay

    Per Hour
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CQV Engineer – Clean Utilities

Role: CQV Engineer – Clean Utilities
Location: Dublin
Contract: 12-month contract
Onsite role
€70 - €80 per hour

At Hays Specialist Recruitment we have a great opportunity for a CQV Engineer to join our Biopharmaceutical client in Dublin on an initial 12-month contract.

Responsibilities
• Development and execution of CQV testing documentation for Clean Utilities for the Sterile Drug product facility.
• Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.
• Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all equipment and utilities are tested in compliance with project-related standards from a commissioning perspective.
• Deviation management associated with the assigned equipment and utilities.
• Risk Management – Identifies and categorises CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
• Execution of FAT testing and leveraging results into the overall qualification process for assigned equipment, facilities and utilities.
• Ensuring all assigned training is executed on time to meet site metrics.

Required Competencies
  • Demonstratable capacity to effectively execute the CQV testing approach assigned from initiation to completion.
  • CQV project lifecycle experience from design through to C&Q and handover.
  • Demonstrable experience of performing as part of a diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
  • Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment and Utilities with integrated automation.
  • Specifically, experience with CQ of High Purity Water systems, Purified Water & WFI Generation and Distribution systems, as well as Clean Steam and High Purity Gas Systems.
  • Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on-time performance.
  • Excellent communication skills and the ability to influence others.
  • Demonstratable experience working in teams in a matrix environment to deliver CQV elements.
  • Previous experience with electronic validation platforms (e.g. ValGenesis, Kneat).

Required Qualification(s) and Desired Experience The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with a minimum of 5 years of experience within the pharmaceutical industry, ideally with familiarity with Sterile Drug Product filling line experience.

The role is a site role.
Req – 64752-1


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Talk to Brendan Coffey, the specialist consultant managing this position

Located in Hays Recruitment, Cork, 54 South Mall, Cork, Telephone: 0860675277
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