Validation Engineer

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.

Summary:

Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, and specification. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors.

What you'll do:

• Calibrate, validate, and test manufacturing equipment and systems used for clinical research, trials and medical device products.
• Perform testing on data analysis equipment.
• Assist in equipment selection, specification and negotiation of competitive pricing.
• Manage Validation projects, manufacturing risk analysis, process control plans and performs validation activities, including developing of validation plans, protocols (IQ/OQ/PQ/TMV) and reports as well as Validation process procedures and other Quality System documentation.
• Maintain all documentation pertaining to qualification and validation.
• Lead projects in optimizing the efficiency, capability and effectiveness of manufacturing processes through strategic process improvement. (NC or CAPA projects)
• Closely collaborate with Manufacturing, Manufacturing Engineering and New Product Introduction (NPI) in planning and execution of Validation activities of Manufacturing processes and equipment in Manufacturing Operations/Production.
• Actively participate in defining activities to assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, ISO 13485, MDSAP, MDD and EU MDR).
• Design and perform process characterization studies and DOEs to develop new and/or improve existing assembly processes with Manufacturing/Industrial Engineers.
• Support data trending and implement statistical process controls for processes by selecting parameters that impact product quality.
• Support and as required, participate in Quality System audits. Serve as information resource for Production and Manufacturing Engineering.
• Serve as information resource for manufacturing validation technicians, contractors, and vendors.

What you must have:

• Bachelor’s Degree (or equivalent experience) with 3-5 years of process validation, equipment validation, or IQ/OQ/PQ experience from a manufacturing environment.
• 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.
• Serve as a mentor to others.
• Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources. Ability to leverage and/or engage others to accomplish projects.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to work with geographically diverse and international teams.
• Strong organizational and follow-up skills, as well as attention to detail.

What would set you apart from others:

• Prior medical device experience preferred i.e. experience working with and understanding Quality System requirements in the medical device industry, such as GMP, 21CFR820, ISO 13485:2016, EU MDR.
• Experienced in problem solving techniques involving Lean/Six Sigma statistical tools such as Minitab
• Experienced in using Lean Management Tools: Kaizen, 6S, Kanban.

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

Equal Employment Opportunity Statement

Varian is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more,

Pay Transparency Non-Discrimination Provision

Varian follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more,

The base pay range for this position is

Min $86,200 - Max $150,900The pay wage range shown is based on the job posting's primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location.