LSC have a great contract opportunity for a QA CSV Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 5 years previous industrial experience in a similar role and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- This contract position will be in the Sterile Drug Product QA Technical Operations team.Reporting to the Snr Manager, Sterile Drug Product, QA Technical Operations for Sterile Drug Product.
- This role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. They will support GMP design reviews, and CQV / CSV / Automation through all phases of the project up to and including Equipment PQ.
- The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.
Responsibilities:
- Provide support to start up activities (Design, Build, CSV / CQV), and GMP operational readiness
- Partnership with CSV & CQV teams in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath, including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and documentation for manufacturing operations.
- Collaboration with functional areas for qualification to ensure knowledge transfer and robustness of control strategies.
- Drives and supports culture of continuous improvement initiatives and safe working practices.
- Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor/Masters in Engineering, or Science related discipline with a minimum of 5 years' experience in Sterile Drug Product Manufacturing
- Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
- The candidate will have proven success working well in a team environment
- Detailed knowledge of Sterile Drug Product would be a distinct advantage.
- Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
- Excellent communication and presentation skills are essential.
- Excellent time management and organizational skills along with a proven ability to multi-task
Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
