LSC have an excellent opportunity for a CSV Engineer to join our team at our Dublin based biopharmaceutical client. Our biopharma client is Blanchardston and is currently builidng a Bulk Drug Substance manufacturing facility that is expected to be fully operational in 2019. As CSV Engineer you will develop and contribute to Project Lifecycle and Test documentation and will also assist in the execution of testing for the BDS plant in line with agreed timelines for this key capital project.
This biopharmaceutical company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
As CSV Engineer you will be responsible for:
o Automation Design, Commissioning, Qualification and Validation documentation – drafting, reviewing and approving CSV related elements of documentation as appropriate.
o Co-ordinate and execute CSV related commissioning, qualification and validation activities where applicable.
o Accountable for scheduling, tracking, reporting and achieving project deadlines.
o Input into the core aspects of Operations, Qualification and Validation SOP’s.
o Actively contribute to project teams.
o Attends Departmental and Team meetings focused on CSV activities.
o Serve as a CSV representative for internal technical group discussions.
o Understanding and applying industry specific compliance standards/regulations to all Commissioning/Qualification activities.
As CSV Engineer you will have:
o Degree level qualification in Science or Engineering or equivalent.
o Commissioning, qualification and validation experience in vaccine or sterile product manufacturing and building management would be an advantage (min 3 – 5 years)
o Experience with ISA S95 and S88 standards.
o Experience in HPRA/FDA environment.
o Experience with MES Systems – preferred but not required (Werum PasX, Emerson Syncade, etc.).
o Experience with Process Control & Building Management Systems – preferred but not required (DeltaV, Siemens, Allan Bradley).
o Experience with OEM Systems – preferred but not required.
For full details on this role please contact Kathy Gillen on 021 4777329 or apply directly through this advert