Validation Engineer (Thermal Systems)
| Job Type | Contractor |
| Area | Westmeath, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3492 |
| Job Views | 167 |
- Description
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
