Lead Commissioning

Vor 2 Tagen

Aarau, Aargau, Schweiz Itech Consult Vollzeit

Project:

We are actively seeking a dedicated Lead Commissioning & Qualification Engineer professional to join our

client's team. This pivotal role involves overseeing and executing commissioning and qualification processes

within a dynamic pharmaceutical environment. Your expertise will ensure compliance with industry standards

and contribute to the successful delivery of high-quality pharmaceutical products.

Tasks & Responsibilities:

  • Lead and manage commissioning and qualification activities ensuring alignment with GMP standards.
  • Oversee the execution of CQV processes, providing expert guidance and strategic direction.
  • Coordinate with cross-functional teams to support the commissioning of fill and finish utilities.
  • Implement and manage project plans for liquid and lyophilized vial filling lines.
  • Develop and review qualification documents, ensuring compliance with industry regulations.

Requirements:

  • Minimum of 5 years' experience in Commissioning and Qualification (CQ).
  • At least 5 years of experience working under Good Manufacturing Practice (GMP) standards.
  • Proven track record as a CQV-Lead or Project Manager for a minimum of 5 years.
  • Experience in a Pharmaceutical or Bio Science "Contract Manufacturing" business.
  • Proficiency in managing fill and finish processes and related utilities for at least 3 years.
  • Nice to have: Diploma level degree in Mechanical or Chemical Engineering.
  • Nice to have: Minimum of 3 years' experience with liquid and lyophilized vial filling lines.

Languages:

  • English fluency (C1 / C2 Level)
  • German Nice to have

Reference Nr.: 924534FC

Role: Lead Commissioning & Qualification Engineer

Industry: Pharma

Work Location: Aarau, Stein

Workload: 100%

Start: ASAP

Duration: ++12 month

Job Type: 100%

Work Location: On the road

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