Validation Engineer (Quality)

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as QuidelOrtho, we are seeking a Validation Engineer reporting into the Quality organization. As a Quality Validation Engineer, you will support all areas of Validation including product and process validation, equipment qualification (including continued process verification) and software and spreadsheet validation.

This position is in Raritan, NJ.

• The Validation Engineer provides support in performing equipment, process, facility and utility qualification and re-qualification activities to ensure compliance to cGMP and site Quality requirements.

• Generates qualification reports to summarize results.

• Assist in the preparation/ execution of Installation Qualification (IQ)/Operational Qualification (OQ)/ Performance Qualification (PQ) protocols for process, equipment, facility and utilities as well as related software.

• Closely works with the maintenance & facility teams to complete new equipment installation as per project requirements.

• Identify deviations encountered during IQ/OQ/PQ execution and work with team to implement mitigation solution.

• Perform other work-related duties as assigned.

Required:

• Associate's Degree in an Engineering or Scientific related discipline and 2+ years of work experience in the Pharmaceutical Industry or other cGMP environment; -OR- a Bachelor's Degree (BA/BS) in a Pharmaceutical, Manufacturing, Engineering, Science discipline.

Preferred:

• Prior work experience with medical devices or cGMP practices per FDA and ISO requirements and/or regulations preferred.

• Temperature mapping or previous experience with temperature data logger equipment a plus.

• Excellent technical writing skills and good documentation practices.

• Excellent oral communication skills.

• Ability to work both independently and in conjunction with a team.

• Internal Partners: Coordination and collaboration with Manufacturing, Engineering, Quality Assurance and Product Support personnel for all aspects of the duties listed above.

• External Partners: Communication with external suppliers, vendors and regulators as required. In the rare event contact with customers may be needed.

The work environment characteristics are representative of a typical office environment; no strenuous physical activity, though occasional light lifting of files and related materials is required. 40% of time in meetings, working with the team/other cross functional teams, or talking on the phone, 60% of the time at the desk on computer, doing some technical and non-technical related work. Flexible work hours to meet project deadlines as needed.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $53,000 to $96,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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