CQV Manager

vor 1 Woche


Frankfurt am Main, Hessen, Deutschland Pharmatec Srl Vollzeit 80.000 € - 120.000 € pro Jahr

We are looking for an experienced 
CQV Manager
 to join a major pharmaceutical facility project in 
Frankfurt, Germany
. This is a full-time, on-site role within a highly regulated GMP environment, supporting the delivery of a large-scale capital project in close coordination with Construction, Engineering, QA, and Project Controls teams.

The ideal candidate has solid experience in Commissioning, Qualification & Validation for pharmaceutical or biotech facilities and is comfortable leading multidisciplinary teams through all CQV phases.

Key Responsibilities

  • Lead and oversee all CQV activities across systems (utilities, clean utilities, HVAC, process equipment, automation, and related subsystems).
  • Develop and manage CQV strategies, plans, schedules, protocols (IQ/OQ/PQ), and documentation in alignment with project and regulatory requirements.
  • Coordinate with Engineering, Construction, QA, and Operations to ensure readiness for commissioning, qualification, and handover.
  • Ensure compliance with GMP, GEP, and applicable regulatory guidelines throughout the project lifecycle.
  • Identify risks, deviations, and blockers, proposing mitigation strategies and ensuring timely resolution.
  • Manage vendors, supervise execution of protocols, and ensure alignment of all involved stakeholders.

Provide clear reporting to project leadership and support decision-making with data-driven insights.

Requirements

  • Proven experience as a 
    CQV Manager
     or senior CQV professional in 
    pharmaceutical or biotech facility projects
    .
  • Strong knowledge of GMP, GEP, validation lifecycle, and regulatory expectations (FDA/EU).
  • Experience working on large capital projects (utilities, clean rooms, process equipment)
  • Familiarity with integrated project environments and multidisciplinary coordination.
  • Fluency in 
    German
     (mandatory) and very good command of English.
  • Availability to start 
    as soon as possible
    .
  • Ability to work full-time 
    on site in Frankfurt
    .

Contact mail:
alena.-

Pharmatec SRL is an equal opportunity employer. We welcome applications from all qualified individuals, regardless of race, color, religion, gender, sexual orientation, gender identity, nationality, or disability.



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