TasksDoing the following tasks for the pertinent systems in accordance with project rules and guidelines includes, but is not limited to:
-The creation and approval of the system boundary.
-The planning, execution, and approval of the Design Qualification. This includes IQ release.
-Commissioning planning, carrying out, and approval. This includes oversight of the scope and quality of the vendor's testing.
-The planning, implementation, and approval of the Installation Qualification. This incorporates OQ's release.
-Planning, carrying out, and approval of Operational Qualification. This includes release to OPS.
-Provide assistance with the Design Qualification process for additional direct impact systems.
-Support the installation commissioning process's implementation in compliance with the project's processes and guidelines.
-Whenever judgement required, shall be able to work or assist with another C&Q activity.
-Carry out shift work where required and be available for travel to vendors/contractors
-Minimum of a Bachelor's Degree in either Engineering or Life Sciences
-Minimum of 2+ years of experience in:
-the biopharmaceutical/biotech industry for qualification/ validation (DQ, IQ, OQ) and commissioning
-the qualification/ validation/ commissioning of Clean Utilities Systems
-DeltaV (Emerson) experience
-Fluent in the English language (written and verbal)
-Knowledge of cGMP and regulatory requirements
-Able to work independently and completing tasks on schedule
Preferred additional requirements would be:
-fluent German Language
-familiarity with the Lonza Qualification/ Commissioning approach
- COMOS/ KNEAT knowledge