This employer requests that only candidates in Ireland apply to this job.
You appear to be located in United States, not Ireland, so you will not be able to apply for this job.
New Build state of the art biologics manufacturing facility in Dublin have a contract requirement for an experienced C&Q Engineer.
Working within the CQV Team you will be required to carry out the Commissioning, Qualification and Validation (CQV) studies to complete execution and start-up of the project in Dublin.
After project completion this position will transition to continue validation activities and change control in support of the ongoing operations of the plant.
We have a number of positions available for CQV Engineers with a background in one of the following areas:
CSV Area of responsibility will be in one of the following work streams -process support equipment, cleaning validation, CSV, SIP Validation HVAC and Utilities or general support.
Key responsibilities will include (depending on experience and area of responsibility):
CQV for equipment in one of the following areas associated with the manufacturing of biologics drug substance:
Process support equipment including glasswashers, autoclaves and environmental chambers
HVAC and Utilities
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 Senior Validation Engineer 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. 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
Commissioning/Validation of any of the following:
Problem solving ability and excellent oral and written communications skills
Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)