CQV Engineer

☞ Randstad Switzerland

View: 158

Update day: 25-03-2024

Location: Visp Valais VS

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Staffing Recruiting Biotechnology Research Pharmaceutical Manufacturing

Position: Entry level

Job type: Temporary

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Job content

We are looking for a CQV Engineer (m/f/d) for Lonza AG (100%). This is a temporary position for 12 months.

Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there’s no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work Lonza wants to be part of.

Key Responsibilities

As part of the CQV Team reporting to the CQ Manager main responsibilities and tasks of the incumbent includes but are not limited to:
  • Attendance at Factory Acceptance Tests for key process equipment to witness and validate the following:
    • Compliance with URS, DQ and FAT protocols.
    • Assess vendor compliance with applicable codes and standards.
    • Raise punch items and sign off on FAT report.
  • Execution of Walk Down of mechanically complete (MC) systems including: Verification of installation in compliance with design and Client requirements; Identification of any technical issues as well as ergonomic or operational defects or clashes in the installation etc.
  • Execution of Installation Verification (IQ) including: Verification of documentation for critical elements of the system; Verification of the installation of all Delta V components etc.
  • Execution of Operational Verification (OQ)
  • Compliance with schedule including completion of tasks in a timely fashion on or before scheduled date; as well as reporting progress of systems status and % completion etc.
  • Safety Compliance including: Preparation/ review of effective risk assessments and method statements; Ensuring safe handover of systems with all LOTO, communication and training to make a safe and effective handover etc.
  • Education: Minimum BS or equivalent in Engineering or Science - preferably in Automation, Chemical, Mechanical or Pharmaceutical Engineering.
  • Experience in Commissioning and Qualification of Clean Utilities and gases.
  • Experience in Commissioning and Qualification for the following equipment:
    • HVAC.
    • Buffer prep and hold
    • Single Use Mixers;
    • Tangential Flow Filtration;
    • Chromatography.
    • COTS (freezers, fridges, probes (pH and UV))
  • Languages:
    • English: Essential fluent in speaking and writing.
    • German: Essential fluent in speaking and writing
  • A minimum of 10 years working experience
  • Broad knowledge of engineering disciplines, commissioning, compliance, qualification and validation.
  • Excellent knowledge of Validation processes (IQ/OQ/PQ) and current regulatory requirements related to E2500 and ISPE 2004.
  • Experience working within a GMP manufacturing environment.
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Deadline: 09-05-2024

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