LSC require a CQV Engineer to coordinate the global Shipping Validation activities for a multimillion dollar Biotech facility based in Dublin. Our client is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
The CQV Engineer will co-ordinate and execute Global Shipping validation activities for Temperature Controlled shipments via air, road and short sea and responsibilities will include drafting, reviewing and approving of shipping documentation and be accountable for the following validation activity linked to this global projects.
Responsibilities will include:
o Inspection support for validation activities (Internal and External)
o Passive shipper qualification for the Shipping and Distribution of temperature controlled products
o Shipping lane assessment and qualification for the introduction of new lanes and products
o Review of current shipping systems
o Introduce new shipping system for frozen material via international airfreight
o Responsible for the core aspects of Shipping Validation SOP’s, specifications and validation plans
o Actively contribute to project teams.
o Performing data analysis and determine conclusions reached.
o Make informed decisions / recommendations around conclusions reached from data analysis.
Education and experience:
o Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
o Commissioning, qualification and validation experience in vaccine or sterile product manufacturing would o be an advantage (min 3 – 5 years)
o Thermal mapping experience using a thermal mapping system such as Kaye or Expert Val
o Experience in IMB/FDA environment advantageous.
o Strong technical writing and communication skills
Please contact Kathy at LSC on 021 4777 329 for full details of this CQV role or apply directly through this advert