CQV Engineer - Analytical Equipment

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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 – Analytical Equipment

Role: CQV Engineer – Analytical Equipment
Location: Dublin
Contract: 12-month contract
€65 - €75 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.

In association with the SDP Area, the CQV Lead prepares and executes the site commissioning and validation testing for equipment utilities at the Drug Product Facility in alignment with site and global procedures.

Responsibilities
• Development and execution of CQV testing documentation for benchtop, mobile, analytical, PAT, incubators, BSCs, and TCU equipment 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 is tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all equipment is 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 small equipment with integrated automation.
  • 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 3–5 years of experience within the pharmaceutical industry, ideally with familiarity with Sterile Drug Product filling line experience.

The role is a site role.

Req – 64749-1


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.


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Talk to Pawel Jurkiewicz, the specialist consultant managing this position

Located in Hays Recruitment, Cork, 54 South Mall, Cork, Telephone: +35315827744
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