CQV Engineer Role
We are hiring a CQV Engineer to join our team at GerTEK, a leading engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
Our client, a major life science & technology company, is seeking an experienced professional to support the commissioning and qualification of new aseptic manufacturing equipment.
Key Responsibilities:
* Commissioning & Qualification of new aseptic manufacturing equipment.
* Writing and execution of qualification documentations such as FAT, SAT, IOQ, PQ protocols.
* Providing technical assistance during investigations or process/equipment improvements.
* Ensuring on-time execution of schedules and reports.
* Collaborating with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements.
* Ensuring validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.).
* Providing change control assessments which could impact the validated state of process equipment.
* Leading Risk assessments, root cause analysis and investigations as applicable.
Equipment Qualification:
We are looking for experience with the following equipment: Single Use Equipment, Mobile Equipment - SUM/TCU/Utility Panels/Reactor Facility Qualification OR Fine Line (Vial / Syringe ) / Lyo /Capper / External Vial Washer.
About the Role:
This is an exciting opportunity for a motivated CQV Specialist to join our team and contribute to the delivery of strategic projects with technically strong personnel ensuring all important activities meet both current requirements and client needs.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.