12147492 – Validation Engineer IV – Athlone Contractor

Purpose:

This is a 12-month Fixed Term Contract

Our client is looking for the Syringe Filling Line CQV SME in order to deliver a Line upgrade to the Syringe format with the following scope of work:

Responsibilities:

• Insert Responsibilities Bullet Points Ownership of the Line Qualification Lifecycle document using Risk-Based Verification Approach (ASTM E2500)
• Oversight/Execution of the vendor SAT testing and Execution of the Company Verification Test Scripts
• Oversight of the Vendor VHP CD/PQ
• Oversight of the Autoclave sterilization cycle (Cycle Development and PQ) for the format contact parts
• Driving and execution of the Air Visualization Studies

Minimum Qualifications and Experience: 

• Bachelor’s degree required as a minimum
• 9+ Years of Experience
• Understanding of the Risk-Based Qualification Approach applied knowledge of ISPE C&Q and ASTM E2500
• Understanding of the Filling Isolator Concept
• Hands-on experience with Installation and Verification test execution
• Understanding of the Non-Touch-Transfer Technology
• Understanding of the VHP Cycle Development and Performance Qualification
• Understanding of the Autoclave Sterilization of the porous loads
• Project Management Skills
• Good Communication Skills