Senior Process Engineer

The Opportunity

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 6000 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.

The Role

At QuidelOrtho were advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Process Engineer. This position provides direction and support to the manufacturing area utilizing structured problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include but are not limited to monitoring of current manufacturing processes reduction of variation control/mitigation of process drift leading / supporting troubleshooting investigations implementing manufacturing process improvements assessing feasibility of new manufacturing technology ensuring manufacturing process robustness revising/creating new documentation for Manufacturing (manufacturing instructions routings bills of material SOPs etc.) validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing.

This position will be onsite in Carlsbad CA.

The Responsibilities

• Provide technical and strategic leadership in the design development and optimization of manufacturing processes for diagnostic reagents and related products ensuring scalability robustness and long-term operational excellence.

• Lead cross-functional collaboration with R&D Quality Operations Regulatory and Supply Chain to define refine and standardize process specifications that align with business objectives and compliance requirements.

• Drive continuous process improvement initiatives leading efforts to characterize optimize validate and implement Engineering Change Orders (ECOs) to enhance efficiency reduce variability and strengthen process capability.

• Own and lead technical investigations related to NCMRs CAPAs deviations and failure analyses within the Chemistry Manufacturing area ensuring timely root cause identification risk mitigation and sustainable corrective actions.

• Lead/support internal and external manufacturing audits partnering with cross-functional stakeholders to assess process performance identify gaps and implement effective corrective and preventive actions.

• Serve as the process engineering lead in R&D-to-Manufacturing transfer activities guiding scale-up strategies assessing production readiness and ensuring seamless integration into commercial manufacturing.

• Champion adherence to the Quality Management System modeling compliance excellence and reinforcing alignment with business policies regulatory standards and industry best practices.

• Drive Lean and Six Sigma deployment mentoring team members and leading structured improvement projects to elevate product quality increase throughput and strengthen operational efficiency.

• Act as a technical mentor and thought leader within the Process Engineering function elevating team capability and fostering a culture of accountability innovation and continuous improvement.

• Performs other duties & projects as assigned

The Individual

Required:

• Bachelors degree in Chemistry Biochemistry Engineering or related field.

• Minimum of 8-10 years experience in process engineering with a background in the fields of diagnostics biochemistry or immunochemistry.

• Experience with regulatory compliance standards (e.g. FDA ISO).

• Good problem-solving skills including root cause analysis and data driven decision making.

• Excellent teamwork and communication skills.

• Knowledge of statistical tools and data analysis software such as JMP Excel and Minitab.

• Working knowledge of manufacturing tools and processes (i.e. BOM Routings SPC Charts)

• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience in lateral flow technology preferred.

• Experience with antibody purification processes.

• Experience with analytical method development (ELISA HPLC Flow Cytometry).

• Key Working Relationships

• Deals with all technical functions (Chemistry Manufacturing Engineering Quality R&D and Regulatory) on a continual basis presenting technical expertise and support as needed. Works with Chemistry Manufacturing to address manufacturing problems solutions and improvements in the manufacturing areas. Participates in cross-functional teams and may lead / support interdepartmental project team/s.

• The Work Environment

• The work environment characteristics are representative of both an office and laboratory environment and may include handling of viral and bacterial hazards potentially hazardous chemicals as well as infectious or potentially infectious bodily fluids tissues and samples. Flexible work hours to meet project deadlines.

The Physical Demands

Position requires ability to lift up to 20 lbs. on occasion. Up to 75% of time at lab bench or desk walking standing and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

Salary Transparency

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 $102360.25 - $130000 USD Annual annually. 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.

Equal Employment Opportunity

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 .

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