Senior Process Engineer

QuidelOrtho unites Quidel Corporation and Ortho Clinical Diagnostics to create a world‑leading in‑vitro diagnostics company. We are more than 6,000 strong and operate in over 130 countries, delivering fast, accurate, and consistent testing from hospital to clinic. Role Overview Senior Process Engineer – responsible for providing direction and support to manufacturing, resolving issues that impact product quality and delivery. Position is onsite in Carlsbad, CA. Responsibilities Provide technical and strategic leadership in design, development and optimization of manufacturing processes for diagnostic reagents and related products. Lead cross‑functional collaboration with R&D, Quality, Operations, Regulatory, and Supply Chain to define, refine, and standardize process specifications. Drive continuous process improvement initiatives, including Engineering Change Orders (ECOs) to enhance efficiency, reduce variability, and strengthen capability. Own and lead investigations related to NCMRs, CAPAs, deviations, and failure analyses within the Chemistry Manufacturing area. Lead and support internal and external manufacturing audits, assessing performance, identifying gaps, and implementing corrective actions. Serve as the process engineering lead in R&D‑to‑Manufacturing transfer activities, guiding scale‑up strategies and ensuring integration into commercial manufacturing. Champion adherence to the Quality Management System and reinforce alignment with regulatory and industry standards. Drive Lean and Six Sigma deployment, mentoring team members and leading projects to elevate product quality and operational efficiency. Act as a technical mentor and thought leader within Process Engineering. Perform other duties and projects as assigned. Qualifications Bachelor’s degree in Chemistry, Biochemistry, Engineering or related field. 8–10 years of experience in process engineering in diagnostics, biochemistry, or immunochemistry. Experience with regulatory compliance standards (e.g., FDA, ISO). Strong problem‑solving skills, root cause analysis, and data‑driven decision making. Excellent teamwork and communication skills. Knowledge of statistical tools and software such as JMP, Excel, and Minitab. Working knowledge of manufacturing tools and processes (e.g., BOM, Routings, SPC Charts). Preferred Experience Lateral flow technology. Antibody purification processes. Analytical method development (ELISA, HPLC, Flow Cytometry). Key Working Relationships Collaborate regularly with Chemistry, Manufacturing, Engineering, Quality, R&D, and Regulatory functions. Participate in cross‑functional teams and lead or support interdepartmental projects. Work Environment Forces include office and laboratory settings; handling of viral/bacterial hazards, hazardous chemicals, and potentially infectious bodily fluids. Flexible work hours may be required to meet project deadlines. Physical Demands Ability to lift up to 20 lbs on occasion. Up to 75% time at lab bench or desk, walking, standing, and sitting for long periods. Vision required for close and distance tasks. Personal Protective Equipment required. Salary Annual salary range: $102,360.25 – $130,000 USD. Benefits Medical, dental, vision, life, and disability insurance. 401(k) plan. Employee assistance program. Employee Stock Purchase Plan. Paid time off, sick time, and holidays. Equal Employment Opportunity QuidelOrtho believes in Equal Opportunity for all. We are committed to ensuring all individuals, including those with disabilities, have an opportunity to apply for positions they 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. Reasonable accommodations are available for qualified individuals. For assistance, contact View email address on click.appcast.io. #J-18808-Ljbffr