Description
A major global biopharmaceutical organisation with global operations in Ireland is seeking multiple CQV Engineers (Commissioning Qualification Validation) for their substantial greenfield project in Ireland.This is one of the Ireland's largest investment projects and is scheduled to complete in 2019.
We are seeking experienced Engineers with varied backgrounds including process/ancillary equipment, biopharmaceuticals, including upstream and downstream and utilities, with varying levels of experience for this sizeable project. Key equipment requirements include: Bioreactors, vessels, centrifuges, chromatography columns, ultrafiltration, diafiltration, parts washers, hoists, mobile vessels.
The Engineer will use the Risk-Based Verification (RBV) approach to execute commissioning and qualification activities on this start up biopharma project. The role is a contract position as part of the CQV team.
Principal Responsibilities:
- Membership of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel).
- Planning of Own Activities.
- Ownership and Closure of open issues (Punch Items, Non-Conformances etc).
- To commission Bio-Process systems with DeltaV automation.
- To review & approve automation FDS for DeltaV (CM's, EM's, Graphics & Phases).
- To have a detailed knowledge of specific Bio-Process and Clean Utility unit operations.
- Draft and review CQV test documentation.
- Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines.
- Input into the core aspects of Operations SOPs.
- 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.
- Understanding and applying industry-specific compliance standards/regulations to all CQV activities.
- First-hand experience of a Risk-Based Verification CQV (ASTM E2500) project execution.
- Leading Risk assessments, 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.
- Willingly accepting challenging assignments.
- Proactively keeping up to date with current thinking and best practice.
- Commissioning, qualification, and validation experience in Biopharmaceutical Manufacturing Facility.
- Experience in using DeltaV automation platform and review/approval of associated documentation.
- Experience in IMB/FDA environment advantageous.
- Strong technical writing and communication skills.
- Proven track record in RFT generation of validation/verification documentation.
- Problem solving and Project Management skills.
- Must be goal-oriented and able to prioritise and manage tasks.
- Technical diploma or Degree in Engineering/Life Sciences or greater preferred.