Tech Ops Process Engineer

The Opportunity

Quidel Ortho 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.

The Role

At Quidel Ortho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Technical Operations Process Engineer. This position independently supports manufacturing operations by applying engineering and scientific principles to improve process performance, resolve issues, and ensure product quality. This role leads routine technical activities and contributes to process development, validation, and continuous improvement initiatives.

This position will be onsite in San Diego, CA.

The Responsibilities

* Independently execute process optimization, characterization and validation activities

* Lead portions of technical transfer projects from R&D to Manufacturing

* Own investigations for NCs, CAPAs, and deviations of moderate complexity

* Design and analyze DOE studies; implement data-driven improvements

* Develop process and material specifications

* Author and revise technical documentation (SOPs, validation protocols/reports)

* Execute change plans from feasibility assessment through implementation, ensuring alignment with cross-functional stakeholders and business objectives

* Support supplier qualification activities and material characterization efforts

* Contribute to continuous improvement initiatives

* Ensure compliance with QMS and regulatory requirements

* Perform other work-related duties as assigned

The Individual

Required:

* Bachelor's degree (BS/BA) in Engineering or related technical field

* 3-5 years of experience in a cGMP-regulated manufacturing environment or equivalent

* Strong analytical thinking and structured problem-solving capabilities

* Experience with process development, optimization, scale-up, and standardization

* Proficiency in Design of Experiments (DOE), Statistical Process Control (SPC), and data analysis

* Ability to independently design experiments, interpret data, and make data-driven decisions

* Experience with process validation (IQ/OQ/PQ) and technical documentation

* Knowledge of quality systems, cGMP regulations, and compliance requirements

* Strong project management skills with ability to manage multiple priorities and meet deadlines

* Effective written and verbal communication skills

* Ability to work both independently and collaboratively across cross-functional teams

* Proficiency with standard computer applications (e.g., Microsoft Office, data analysis tools)

* Ability to troubleshoot and resolve complex technical issues with minimal supervision

* Strong organizational skills and attention to detail

* Demonstrated ability to drive continuous improvement initiatives

* Capable of working in a fast-paced, regulated manufacturing environment

* This position is not currently eligible for visa sponsorship.

Preferred:

* Six Sigma certification (Green Belt or Black Belt)

The Key Working Relationships

Internal Partners:

Quality Control, Quality Assurance, Manufacturing, R&D, Chemistry, Regulatory, Engineering and Supply Chain

External Partners:

Suppliers and Customers

The Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples

The Physical Demands

Sitting, standing, walking, lifting, carrying, reaching, pushing,…