Risk and Validation Engineer

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 and other types of solid cancers.

As part of the effort to extend Novocure’s Operations Engineering department, we are looking for a Risk and Validation Engineer.

This is a full-time, exempt position located in our Krakow Poland office and reports to the Manager of Process Validation and Equipment LCM - Operations. The role is hybrid and requires physical presence at the office 3 times per week.

JOB SUMMARY

The primary responsibilities include managing different aspects of Novocure’s process and equipment validation programs.  Ensure validation programs meet requirements of FDA and ISO, and process compliance.

Along with the execution and planning of internal and external validations, this position will also be responsible and accountable for the execution of the requirements related to the Risk Management activities. This position will maintain and regularly update the pFMEA and relevant documentation, identifying the risks and proposing/implementing mitigations.

This position will also support internal audits at specified intervals and report audit findings, promote continuous improvement of systems, products, and services.

The position may also participate and support the calibration and preventive maintenance programs of measuring devices and test equipment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for creation of high level test plans validation assessments and validation plans, oversee their progress and completion
• Responsible to review and approve test methods, validation test plans and results.
• Responsible for Validation samples management
• Act as a point of contact for subcontractor test laboratories
• Conduct of internal audits per annual program
• Relevant Issue/NCMR/CAPA management
• Serves as SME for validations at internal and external audits

QUALIFICATIONS/KNOWLEDGE:

• University degree in a scientific discipline or related Engineer/Science qualification (Minimum BSc and preferably Electronics) with a minimum of 3 years working as a quality engineer in a multi-national medical device manufacturing & distribution environment.
• Proficient with qualification / validation of test methods and manufacturing processes including equipment used for validation/ verification/manufacturing.
• Proficient in utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, etc). A Six Sigma certification will constitute a preferential title.
• Proficient in planning and overseeing execution of product validation studies (pharma and/or medical device industry experience is a must).
• Good understanding of electro-medical devices and relevant regulations is advantageous.
• Working knowledge of the FDA medical device Quality Systems Regulations. Prefer a solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, MDR).
• Excellent English
• Strong knowledge of quality system regulations.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
• Ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management

OTHER:

• Exceptional organizational skills
• Committed
• Patient oriented
• Details oriented
• Excellent analytical skills 
• Flexible and adaptable
• Able to work on own initiative and as a team player
• Able to build good, strong and positive working relationships with cross-functional teams
• Able to work within tight and unpredictable time constraints
• Able to travel abroad from time to time