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