CQV Engineer Job Opportunity
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies to deliver strategic projects with technically strong personnel ensuring activities meet current requirements and client needs.
### Key Responsibilities:
* Commissioning & Qualification of new aseptic manufacturing equipment.
* Writing and execution of qualification documentations such as FAT, SAT, IOQ, PQ protocols.
* Support for development of URS and Functional Specification associated with aseptic processing.
* Technical assistance during investigations or process/equipment.
* On-time execution of schedule and reports.
* Periodic Review plans are completed per site & regulatory requirements.
* Collaboration with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements.
* Validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.).
Requirements:
- Previous experience in execution of aseptic equipment/qualification/aseptic processing.
- Advanced knowledge of FAT, SAT, IOQ Risk-based verification.
- Previous experience on Kneat/online validation package.
### Benefits:
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated CQV Specialist seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.