Validation Engineer
- Midlands (Ireland)
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Dublin is a hive of activity for the Life Sciences Industry at present, with global organisations investing heavily in new facilities here. An excellent opportunity has arisen with one of the largest Biotech Manufacturing organisation in Ireland in the picturesque County Westmeath.
Duties:
Syringe Filling Line CQV SME required to deliver Line upgrade to the Syringe format with the following scope of work:
- Ownership of the Line Qualification Lifecycle document using Risk Based Verification Approach (ASTM E2500
- Oversight/Execution of the vendor SAT testing and Execution of Verification Test Scrip
- Oversight of the Vendor VHP CD/P
- Oversight of the Autoclave sterilization cycle (Cycle Development and PQ) for the format contact part
- Driving and execution of the Air Visualization Studies
- Strong experince with Syringe Filling Line CQV
- Understanding of the Risk-Based Qualification Approach, applied knowledge of ISPE C&Q and ASTM E250
- 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
For more information on this position, please apply with your up to date CV today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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