Short Job Description:
The CQ Engineer delivers commissioning and qualification services for equipment such as temperature controlled equipment / temperature controlled unit, warehouse, laboratory equipment (e.g., TOC analyzer, micro plate reader, MALDI-TOF, HPLC, osmometer), manufacturing support equipment (e.g., weighing balance, pH meter, weighing balance, CEDEX, ViCell, Solo VPE), HVAC, utilities (e.g., WFI, compressed air) and process equipment. The Engineer ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.
Key Responsibilities:
Deliver CQ services to support introduction, upgrade or decommissioning of manufacturing, manufacturing support and laboratory equipment in the Life Sciences (pharmaceutical / medical device) clients. Draft equipment qualification deliverables such as URS, risk assessment, data integrity related assessment, CQ (IQ/OQ) protocols, specifications and RTM. Re...