Commissioning and Qualification CQV Engineer
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 who entrust in us to deliver their most strategic and important projects.
We are hiring a CQV Engineer for our Sligo Based Client.
Responsibilities
* Commissioning & Qualification of new aseptic manufacturing equipment
* Writing and execution of qualification documentations such as: FAT, SAT, IOQ, PQ protocols
* Provide Support for the development of URS and Functional Specification associated with aseptic processing
* Provide technical assistance during investigations or process/equipment
* Ensures on-time execution of the schedule and reports
* Ensures Periodic Review plans are completed per site & regulatory requirements
* Collaborates with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements.
* Ensures validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.).
* Provide change control assessments which could impact the validated state of process equipment.
* Leading Risk assessments, root cause analysis and investigations as applicable.
* Own departmental SOPs and ensure they follow corporate standards and applicable regulations.
Equipment: Single Use Equipment, Mobile Equipment – SUM/TCU/Utility Panels/Reactor Facility Qualification or Fine Line (Vial / Syringe) / Lyo /Capper / External Vial Washer.
Qualifications
* 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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Project Management
Industries
Engineering Services and Pharmaceutical Manufacturing
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