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.
- 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 firstname.lastname@example.org.