LSC have a requirement for a CQV CIP Lead to join the CQV team with our global biotech manufactruing 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.
As CIP Lead you will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in this Bulk Drug Substance (BDS) manufacturing facility in Dublin. 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 CIP Lead you will:
o Lead and plan the CQV CIP Team activities
o Oversee the start up and commissioning of CIP systems in a Biological and / or Pharma Environment with DeltaV automation
o Oversee the review & approval of automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
o Take part in troubleshooting and remediation project teams.
o Oversees sprayball coverage testing on CIP and process vessels.
o Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines.
o Understanding and applying industry specific compliance standards/regulations to all CQV activities.
o Leading Risk assessments, root cause analysis and investigations.
o Generation and review of protocols, reports, project change controls and deviations.
o Proactively highlighting any issues around compliance.
A CIP Lead 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 7 – 10 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 sprayball coverage testing in process vessels essential.
For full details on this role please contact Kathy on 021 4777329 or apply directly through this advert.