LSC have a requirement for a CQV Engineer – Purification/Downstream required for LSC’s client on a Green Field site in Blanchardstown Dublin
As the CQV Purification Engineer you will:
o Participate in a CQV Team with key emphasis on: Membership of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel). Planning of Own Activities. Ownership and Closure of open issues (Punch Items, Non-Conformances etc)
o Commission Bio-Process systems with DeltaV automation
o Review & approve automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
-Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
-Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 – 5 years).
o Experience in Purification or related bioprocess manufacturing experience in an established biotech production operation.
o Experience in using DeltaV automation platform and review/approval of associated documentation essential.
o Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
o Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
For full details on this role please contact Kathy on 021 4777329 firstname.lastname@example.org or applly directly through this advert.