As part of a significant expansion of our client site, an exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients.
Responsibilities:
Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation)
Authoring project validation master plans; SOP and documentation updates;
Authoring validation protocols and final reports, executing validation studies, analysis of validation data;
Resolving technical issues encountered during study execution.
This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives. Minimal work direction needed, highly skilled and knowledgeable to the position.
Experience:
There are 4 broad technical areas that will require experienced, energetic and committed engineers -
(1) Sterilisation - Autoclaves, SIP of vessels
(2) Cleaning - Parts Washer and CIP of vessels
(3) Vial and Syringe filling operations -Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection.
(4) Vial and Syringe Sterility operations - Isolators, VHP, E-Beam and Depyrogenation systems. The successful candidate will need to have demonstrated experience in one or more of these areas.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.