LSC have a great contract opportunity for a Validation Engineer to join a global Biopharmaceutical company in Carlow.
This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have 6 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you
ABOUT THE PROJECT - KEY RESPONSIBILITIES: Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
Implementing the requirements as outlined in the site & project Validation Master Plan(s).
Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.
Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
Supporting regulatory submissions as required Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
Experience with liaising with other departments - Engineering, Automation, Technical, Operations, EHS and QA Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
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
Apply via this advert or contact Grinne Hodnett at LSC on if you have any more questions about this role
Skills: validation GMP Cleaning validation equipment utilities