LSC have an exciting contract opportunity for a Senior Validation Engineer to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 5 + years (ideally 8 years +) biotech or pharmaceutical industry experience and are ready for your next challenge, this could be the perfect project for you!
As Sr. Validation Engineer you will have validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
o Translates Site requirements into the language of the CMO-can make a risk-based decision
o Validation document author/approver
o Ensure validated parameters are correctly incorporated in Master Batch Records
o Regulatory – Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship
o Validation change control assessment
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Degree qualified in science and/or engineering
o 5 + years (ideally 8 years +) biotech or pharmaceutical industry experience
o Significant Validation experience at Aseptic Manufacturing or API facilities
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Kathy in LSC on 0214777 329 to discuss this Sr Validation Engiener role in more detail or apply directly via this advert.