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 Gráinne Hodnett at LSC on 021 4777329 if you have any more questions about this role!
