Job Description
We are seeking a highly skilled CQV Engineer to join our team at Ger TEK Project Management & Technical Services.
The successful candidate will be responsible for generating, executing, and approving qualification documents for direct impact systems, as well as commissioning test documents for non-direct systems.
Responsibilities
* Generate, execute, and approve qualification documents for direct impact systems (facility, utility, and equipment).
* Create commissioning test documents for non-direct systems.
* Ensure compliance with cGMP and cGDP regulations.
Requirements
* Bachelor's degree in engineering, science, or technical discipline.
* At least 3 years of experience in commissioning and qualification, preferably in the medical device or pharmaceutical industry.
* Familiarity with clean utilities, hygienic piping, process instrumentation, controls, and TOPs.
* Working knowledge of sanitary equipment, hygienic piping, process instrumentation, and controls.
* Familiarity with project management tools is advantageous.
Desirable Skills
* Previous experience with clean utility tie-ins to existing systems.
* Strong interpersonal and teamwork skills.
* Ability to work independently with limited supervision.
* Flexibility to support unexpected project demands.
Main Systems in Scope
* WFI Distillation
* Storage and Distribution Purified Water
* POU Coolers
* Partswasher
* Sterilization
* Autoclave
* VHP Freezers
* Facility qualification
Job Type: Full-time To start the process click the Continue to Application or Login/Register to apply button below.