Operations Engineer - Computer System Validation, Equipment Lifecycle Management, and Testing

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. Currently we are looking a Operations Engineer - Computer System Validation, Equipment Lifecycle Management, and Testing to our office in Cracow, Poland.

The Operations Engineer – Computer System Validation, Equipment Lifecycle Management, and Testing position reports into the Global Operations Engineering organization and is responsible for supporting Novocure’s product manufacturing, testing, and processing. Primary responsibilities include support and execution of CSV Procedure, ELM Procedure, development of test equipment and process requirements, project team participation, and developing and conducting process validations. Additional responsibilities are supporting internal and external audits, CAPA investigations, development and maintenance of SOPs, supporting the collection and analysis of quality metrics, and supporting company expansion plans. Novocure is a rapidly growing business and responsibilities can grow with the company.

RESPONSIBILITIES:

• Develop and execute effective CSV validation protocols and assure completed validations meet requirements, identify risks, and assure expected performance will be realized
• Develop requirements for testing systems
• Lead or participate in testing system development projects
• Perform risk assessments and FMEAs, implement their resultant mitigations
• Develop and update procedures required by the quality system as needed
• Direct involvement with FDA inspections and third party audits
• Investigate Corrective and Preventive Actions (CAPA) as required
• Support Equipment Lifecycle Management Process/Procedure
• Equipment qualification, validation and management of equipment lifecycle
• Help develop, maintain, and analyze quality metrics and trends
• Support product service and/or repair activities as needed

YOUR PROFILE::

• Bachelor’s degree in Electrical, Mechanical, or Systems Engineering or equivalent
• About 2+ years of engineering or quality engineering work experience required
• One plus year of experience in an FDA regulated or similar environment is required – with QSR (21 CFR Part 820) experience preferred
• Experience in a medical device manufacturing and/or product service environment preferred

Knowledge:

• Proven knowledge and application of GAMP requirements is a must
• Proven knowledge in equipment validation and qualification
• Capability and confidence to lead and build consensus a cross-functional teams
• Proficient in Microsoft Office
• High written& communication skills
• Very good project management experience and skills
• Ability to work in a team environment and also execute responsibilities with minimal direct supervision
• Knowledge of FDA and ISO standards for Medical Devices is a plus
• Ability perform efficiently, with a determination to succeed in a complex and challenging environment

BENEFITS:

• Performance related bonus
• Life Insurance
• Multisport card/Benefit system
• Private Medical care
•  ..and more!

We are looking forward to receive your application to Emilia Bagińska, Senior Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com.