Software Validation Specialist

0420 Varian Medical Systems Canada, Inc.; Nova Scotia; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading oncology solutions company in Nova Scotia seeks a Software Validation Specialist to ensure that software products meet regulatory standards. Responsibilities include developing validation plans, executing tests, documenting results, and ensuring compliance with industry regulations. Candidates should possess a Bachelor's in Radiation Oncology and have clinical experience. Strong analytical skills and knowledge of validation methodologies are preferred.

Qualifications

• 2-5 years experience in a relevant field.
• Experience in a clinical or nursing environment required.
• Experience with Varian or similar software tools preferred.

Responsibilities

• Develop validation plans and protocols for software products.
• Execute validation tests according to defined protocols.
• Document test results and analyze test data.
• Ensure compliance with relevant regulations and standards.
• Collaborate with software developers and quality assurance engineers.
• Provide documentation and reports summarizing validation activities.
• Participate in audits and inspections by regulatory agencies.
• Identify opportunities to improve validation processes.
• Provide training and mentoring on validation best practices.

Skills

Strong analytical skills

Attention to detail

Knowledge of validation methodologies

Regulatory knowledge

Clinical experience

Education

Bachelor's degree in Radiation Oncology or equivalent technical field

Tools

ARIA software

Microsoft Word

Excel

PowerPoint

Workday or equivalent ERP

Job description

Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you.

As Software Validation Specialist located in the Nova Scotia office you will ensure that software products meet quality and regulatory standards by designing and executing protocols and procedures in a clinical environment. Responsibilities may include creating test plans, conducting tests, documenting results, analyzing data, and ensuring compliance with industry regulations. Strong analytical skills, attention to detail, and knowledge of validation methodologies and regulatory requirements are preferred for this role. Preferred background in nursing or clinical experience.

What You will do :

• Develop validation plans and protocols : Create comprehensive plans outlining the validation approach and specific procedures for testing software products.
• Execute validation tests : Conduct tests according to the defined protocols, which may involve functional testing, usability testing, and security testing.
• Document test results : Record test outcomes, including any defects or deviations from expected behavior, in a clear and organized manner.
• Analyze test data : Analyze test data to identify patterns, trends, and areas for improvement, and making recommendations for adjustments or enhancements to the software.
• Ensure compliance : Ensure that validation activities comply with relevant industry standards and regulations, such as FDA regulations for medical devices or ISO standards for quality management.
• Collaborate with cross-functional teams : Working closely with software developers, quality assurance engineers, regulatory affairs specialists, and other stakeholders to coordinate validation activities and address issues as they arise.
• Provide documentation and reports : Generate documentation and reports summarizing validation activities, results, and conclusions for internal use and regulatory submission.
• Participate in audits and inspections : Support audits and inspections by regulatory agencies or external auditors by providing documentation, responding to inquiries, and demonstrating compliance with validation requirements.
• Continuous improvement : Identify opportunities to improve validation processes, tolls, and methodologies to enhance efficiency, effectiveness, and compliance.
• Training and mentoring : Provide guidance and training to colleagues on validation best practices, procedures, and tools to ensure consistent and thorough validation across projects and teams.

What You will have :

• Education and Experience : Bachelor's degree (or equivalent experience) in Radiation Oncology or equivalent technical field plus 2-5 years experience
• Experience working in a clinical or nursing environment
• Experience working with Varian software and tools (such as ARIA) or very similar competing technologies
• Experience Level with Business Tools : Proficient in utilizing business tools such as : E-mail, Microsoft Word, Excel, and PowerPoint.
• Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.

LS-OS1

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.

Fighting cancer calls for big ideas.

We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.

TogetherWeFight