Description
A global Biopharmaceutical leader is currently looking for an experienced Validation Engineer (Temp Mapping) to join their team on a new build project based in Ireland.The responsibilities of the Validation Engineer will include:
- To coordinate and execute Global Shipping validation activities for Temperature Controlled shipments via air, road and short sea.
- Shipping validation documentation - drafting, reviewing and approving documentation.
- Accountable for the following validation activity linked to Global projects:
- Inspection support for validation activities (Internal and External).
- Passive shipper qualification for the Shipping and Distribution of temperature controlled products.
- Shipping lane assessment and qualification for the introduction of new lanes and products.
- Responsible for the core aspects of Shipping Validation SOP's, specifications and validation plans.
- Commissioning, qualification and validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 - 5 years).
- Thermal mapping experience using a thermal mapping system such as Kaye or Expert Val.
- Experience in IMB/FDA environment advantageous.
- Strong technical writing and communication skills.
- Ability to close items to completion.