Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for a
CSV-E Engineer
As CSV-E Engineer at Novocure you become a part of our Quality Operations department and will be primarily responsible for supporting Novocure’s product testing. Your responsibilities include the development and execution of CSV-E Validation documentation and development of test equipment requirements and the development and conducting of process validations and supporting the global test equipment program.
Your responsibilities:
- Development and execution of CSV-E validation protocols and assurance that completed validations meet requirements, risks are identified and expected performance will be realized.
- You develop requirements for testing systems and lead or participate in testing system development projects.
- You perform risk assessments and FMEAs and implement their resultant mitigations.
- You develop and update procedures required by the quality system as needed and be directly involved with FDA inspections and third party audits.
- You perform CAPAs as required and help develop, maintain and analyze quality metrics and trends
- You support product service and/or repair activities as needed.
Your profile:
- Degree in Electrical, Mechanical or Systems Engineering or equivalent and at least 2 years’ experience in engineering or quality engineering in a professional work setting.
- You possess proven knowledge and application of GAMP requirements and experience in FDA regulated environments. QSR (21 CFR Part 820) experience is preferred.
- Ideally, you bring experience in a medical device manufacturing and/or product service environment.
- Knowledge of FDA and ISO standards for Medical Devices.
- Good oral and written communication skills in English.
We are looking forward to receive your application to Andreas Pleines, Senior Talent Acquisition Partner, through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.
