Project Lead for Commissioning and Qualification
Our organization seeks a seasoned project lead to oversee the successful execution of commissioning and qualification activities. The ideal candidate will possess extensive experience in project management, with a strong background in commissioning and qualification.
Key Responsibilities:
* Coordinate a team of engineers (+10) ensuring timely completion of tasks and adherence to industry regulations.
* Support the transition to a digitized platform for commissioning and qualification.
* Develop and manage project schedules, budgets, and resource allocation.
* Oversee equipment qualification activities, including factory acceptance testing, site acceptance testing, design qualification, installation qualification, operational qualification, and performance qualification.
* Identify and mitigate project risks while ensuring compliance with quality and regulatory standards.
Qualifications:
* Relevant degree and/or 10+ years of experience in the biotech/pharmaceutical industry.
* Minimum 5 years of experience as a lead CQV professional, managing a team responsible for commissioning and qualification.
* Proven ability to work effectively in fast-paced environments and manage multiple projects simultaneously.
* Strong understanding and experience with risk-based validation processes, aligned with ISPE guidelines.
Benefits:
The successful candidate will have opportunities for professional growth, collaboration with experienced professionals, and involvement in high-profile projects.