CQV Engineer

Job Description:
This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy. Development and execution of equipment and facilities validation protocols is the primary responsibility of this position. Inherent is the responsibility to ensure the accuracy and completeness of each validation study and that each study is acceptable to FDA standards and requirements.

Responsibilities:

Participate in the commissioning, qualification and start-up of various pharmaceutical cGMP process and packaging equipment, utilities & facilities.

Coordinate, develop and prepare installation, operation and performance qualification protocols for production equipment and production related facilities validation. Including the validation of manufacturing and packaging equipment, HVAC, Compressed Air and Purified Water systems.