Validation Engineer

  • Contract
  • Cork

Website Ref:TPM04402

Summary:
We have an exciting opportunity for a CQV Engineer to join our team to work on some very exciting projects. The successful candidate will be the CQV point of Contact, supporting timelines and drafting, reviewing and approving CQV documentation.

Responsibilities:

  • Support ongoing process equipment qualification and new facility qualification.
  • Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work.
  • Takes part in troubleshooting and remediation project teams.
  • 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:

  • 4+ years Commissioning, qualification and validation experience in Pharma or Biopharma.
  • 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.

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