CQV Engineer

  • Contract
  • Dublin

Website Ref:TPM04366

Summary:
Our client is a global bio pharmaceutical company based in West Dublin, currently looking to hire a CQV engineer who will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in the cGMP Bulk Drug Substance (BDS) and Packaging manufacturing facilities.

Responsibilities:

  • CQV documentation – drafting, reviewing and approving CQV documentation.
  • Support ongoing HVAC requalification and new facility qualification.
  • Oversee the start-up and commissioning of new equipment within the Packaging, BDS and Warehouse areas.
  • Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work.
  • Takes part in troubleshooting and remediation project teams.
  • Be the CQV point of Contact on Site Capital projects, supporting timelines and relevant testing.
  • Accountable for ensuring activities are scheduled, tracked, and reported appropriately, and achieving project deadlines.
  • Support the ongoing site requalification program.
  • Leading Risk assessments, root cause analysis and investigations.
  • Review of protocols, reports, project change controls and deviations.
  • Understanding and applying industry specific compliance standards/regulations to all CQV activities.
  • Leading root cause analysis and investigations.
  • Generation and review of protocols, reports, project change controls and deviations.
  • Proactively highlighting any issues around compliance.
  • Participates in internal and external audits and inspections where required.
  • Planning and execution of all commissioning activities in adherence to site safety procedures.
  • Operate in a manner consistent with the site incident and injury free philosophy.

Qualifications & Experience:

  • Commissioning, qualification and validation experience in Pharma or Biopharma Manufacturing Facility (min 4 to 7 years).
  • Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable.
  • Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
  • Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
  • Experience in IMB/FDA environment advantageous.
  • Experience in HVAC qualification/requalification desirable.

To apply for this job email your details to orla.daly@tandempm.ie.