LSC have a requirement for a CQV CIP Engineeer to join the CQV team with our global biotech manufacturing client based in Dublin. This company is a global leader focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
The Commissioning Qualification Verification (CQV) Engineer will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in Alexions cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland. The role is a contract position as part of the CQV team and will be a specialist role in the Clean in Place (CIP) C&Q workstream
As the CQV CIP Engineer you will participates and carry out the CQV CIP Team activities which will include :
o Planning of Own Activities
o Ownership and Closure of open issues (Punch Items, Non-Conformances etc)
o Start up and commissioning of CIP systems in a Biological and / or Pharma Environment with DeltaV automation
o Review & approve automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
o Takes part in troubleshooting and remediation project teams.
o Field Walkdowns of systems as part of transfer of ownership of the system from Construction.
o Generation of qualification documentation.
o Perform sprayball coverage testing on CIP and process vessels.
As the CQV CIP Engineer you will have:
o Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
o Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 – 5 years)
o Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable. Experience working on and knowledge of CIP systems and cleanrooms, including start up.
o Experience in using Delta V automation platform and review/approval of associated documentation essential.
o Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
For full details on this role please contact Kathy on 021 4777329 email@example.com or apply directly through this advert.