Lead Commissioning & Qualification Engineer
Posted 5 days 18 hours ago by ITech Consult
Lead Commissioning & Qualification Engineer - CQ/GMP/CQV-Lead/Pharmaceutical
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: + month
If you are interested in this position, please send us your complete dossier via the link in this advertisement.