Description
CQV Engineer required for a major biopharmaceutical start up project in Dublin.
This is a major CAPEX investment due to run until . Additional CQV support is required on both clean and black utilities and HVAC from FAT to commissioning and handover.
Principal Responsibilities
Technical Application
- Participate in a CQV Team with key emphasis on:
- 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 SOP's.
Safety
- Planning and execution of all commissioning activities in adherence to site safety procedures.
Compliance
- Understanding and applying industry specific compliance standards/regulations to all CQV activities.
- First-hand experience of a Risk Based Verification CQV 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 Bulk Drug Substance 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.