15889211 – CQV Engineer – Dublin Contractor

This is a 12 month contract

Purpose

The CQV engineer will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in the company’s cGMP Bulk Drug Substance (BDS) and Packaging manufacturing facilities in Dublin, Ireland. The role is a contract position as part of the CQV team.

Responsibilities

Technical Application
• 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.

Compliance
• 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.
Safety
• 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.

Requirements

• Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
• Commissioning, qualification and validation experience in Pharma or Biopharma Manufacturing Facility (min 4 – 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.
• Excellent technical abilities with a solid base in engineering.
• Strong technical writing and communication skills.
• Proven track record in generation of validation/verification documentation.