Description
CQV Engineer required to join a global biotech company for an initial 6-month contract in Dublin. This person will be working on the key support weekend shift and ensuring the drive to the handover of the new build biotech facility to operations.This will be working a Wednesday - Sunday or Saturday to Wednesday shift.
Role and responsibility:
- CQV for equipment associated with the manufacturing of biologics drug substance.
- Liaise with CQV start-up team in relation to punch list closure both pre-mechanical completion and during the CQV execution phase.
- Ensure commissioning readiness of all systems to support equipment start-up and PQ testing.
- Liaise with the CQV Lead in relation to generation and approval of: IOQ Summary Reports, Cycle Development Protocols and Reports, PQ Protocols and Reports.
- Write, review and update Standard Operating Procedures (SOP's) and Validation Plans (VPs) in accordance with site and corporate requirements.
- Support execution of all CQV deliverables.
- Ensure timely approval of all Commissioning and IOQ Final Reports for systems.
Responsibilities:
The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with 2.5+ years of experience within the pharmaceutical industry. A Strong background in commissioning/validation and drug substance manufacturing is desired.
- Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9).
- Problem solving ability and excellent oral and written communications skills.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project.