CQV Lead

CQV Lead

CQV Lead

CQV Lead

PM Group

Pharmazeutische Produkte, Arzneimittel

Basel

  • Verifizierte Job-Anzeige
  • Art der Anstellung: Vollzeit
  • 121.500 CHF – 163.000 CHF (von XING geschätzt)
  • Vor Ort

CQV Lead

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Über diesen Job

Intro

PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of 3,500 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.

PM Group is now recruiting for a Commissioning Manager to provide and deliver technical expertise on a key Life Science Project.

This is a Site Based Contract in South Switzerland.

Tasks

  • Develop Level 2 and 3 C&Q (Commissioning & Qualification) Schedule
  • Execution Readiness
  • Doc Preparation management and coordination
  • C&Q execution management and coordination
  • Resource management including C&Q Doc Prep and C&Q Exec
  • Oversight of FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests)
  • Execution of IV (Installation Verification), SU (Single Use) and OFT (Operational Feasibility Testing)
  • Execution of IQ and OQ
  • Maintain C&Q input to level 4 schedule and cost report
  • Coordinate with Ops regarding PQ (Performance Qualification) and engineering runs
  • Adherence to Lonza safety, compliance and quality procedures
  • Progress tracking and monthly report
  • System CFR (Commissioning Final Report) / QFR (Qualification Final Report)
  • Complete System Handover
  • Technical support for Clean Utilities PQ 1 and EM (Environmental Monitoring) PQ 1
  • C&Q Close Out (QFR)
  • Participation as SME during Authority Inspection and audits
  • Control Training status of C&Q team

Requirements

  • +/-10 years of Experience in the field of activity
  • Management of a team is a pre-requisite.
  • Experience in biotechnology is mandatory
  • English is Mandatory, German and French is a +
  • Presence on site mandatory

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