Validation Engineer (Thermal Systems)

Team Horizon is seeking a Thermal Systems Validation Engineer for our client, a biopharmaceutical company based in the Midlands.

Why you should apply:

• Opportunity to leverage your expertise and add value to a broad range of signifigant projects across the site


• Join a company who are driven to continuously innovate and create meaningful  value to patients lives.


•  

What you will be doing:

• Validation documentation – drafting, reviewing and approving Validation documentation.


• Manage contractors as per site contractor management procedures.


• Oversee, witness, and execute where required requalification activities on site Thermal systems.


• Participate in Validation Risk Assessments to determine the level of testing required for equipment changes or new equipment.


• Support sustaining and project Validation activities across Drug Substance and Drug Product Areas


• Input into the core aspects of Operations, Qualification and Validation SOP's where required.


• Maintaining hardcopy records in Document control archive, including reconciliation of Documentation.


• Leading or supporting validation deviations as they occur.


• Supporting closeout of investigation actions for Validation team.


• Ensure Requalification and Periodic Review activities are completed in a timely manner.


• Provide support in areas of commissioning and qualification of HVAC systems where required.


• Report / present out on project updates as required.


• Encourage and sustain a high safety culture and performance within the Validation teams.

What you need to apply:

• 5 years+ relevant experience working in a Validation role in the Pharmaceutical / Biotechnology industry.


• Good knowledge of EN285 and the kill kinetics of Stem Sterilization systems.


• Good knowledge of CTUs thermal mapping requirements.


• Demonstrated ability to work effectively with various departments and resolve issues in structured manner.


• Strong technical capabilities, communication skills, teamwork abilities and initiative.


• Proven ability to work well as part of a team & on own. 


• Goods understanding of the requirements of ISO 14644 and how it supports aseptic manufacturing.


• Good Knowledge of VHP (Vaporized Hydrogen Peroxide decontamination systems)


• Understanding of the Aseptic Manufacturing processes