Job Summary
We are seeking a Biopharmaceutical Process Development Lead to join our team in establishing the Manufacturing Technology department. This role will play a pivotal part in providing engineering support to ongoing requirements and supporting future tech transfer projects.
Key Responsibilities:
* Assist in site setup and project-related activities
* Support package owners on vendor management and equipment or process-related activities and queries
* Generate equipment verification & validation protocols and reports as required
* Review vendor documentation for completeness and accuracy
* Participate in FAT and vendor-related activities
* Support issue resolution during equipment installation, commissioning, and qualification phases
* Participate/Execute/Lead verification & validation related activities as required
* Support CQV execution team as needed
* Ensure equipment is designed and tested to meet the requirements of the process
Requirements:
* Candidates should possess a third-level qualification in a Science or Engineering-related subject
* A minimum of 8 years of experience in a large-scale biopharmaceutical/pharmaceutical facility is necessary
* Experience in establishing a Manufacturing Technology team in a greenfield context is highly desired
* Excellent communication skills, including computer literacy, and the ability to work independently and in a team are essential
* Thorough knowledge of current Good Manufacturing Practices (cGMP) is mandatory
* Experience with the DeltaV MCS platform is preferred
Benefits:
This role offers an opportunity to be part of a world-class biologics services provider with global clients in the biopharmaceutical and healthcare industries.