Senior Process Engineer (R&D)
QuidelOrtho
Summary
As a Senior Process Engineer in our assay development group, you will play a critical role in the design, development, and optimization of manufacturing processes for our diagnostic products. You will work closely with a multidisciplinary team of scientists, engineers, and quality assurance professionals to ensure the quality, scalability, and capability of our diagnostic products. This individual will function as a technical project leader, as well as performing laboratory work. This position will be onsite full-time in Rochester, NY.
Job description
Responsibilities
- Design and optimize manufacturing processes for diagnostic reagents and related products.
- Lead a process improvement team - develop strategy and work plan to achieve project objectives.
- Implement Lean/Six Sigma principles to enhance product quality and increase manufacturing efficiency.
- Conduct process risk assessments, failure mode analysis (FMEA), and root cause analysis to identify and resolve issues.
- Transfer processes to the manufacturing operation and verify process capability against design requirements.
- Maintain accurate records in accordance with the QuidelOrtho Quality System.
- Maintain core expertise in the fields of surface modification, formulation, and coating.
- Maintain a safe working environment through the proactive identification of hazards and risks.
- Collaborate to help a team or work group achieve its goals.
- Perform other work-related duties as assigned.
Required Qualifications
- Education: Bachelor’s or Master’s in chemical engineering or related technical field.
- Experience: Minimum 5 years’ experience in process engineering, preferably in diagnostics, pharmaceuticals or biotechnology.
- Strong problem-solving skills, including root cause analysis and data driven decision making.
- Excellent teamwork and communication skills.
- Knowledge of safe chemical and biological handling.
- Ability to travel (<10%).
Preferred Qualifications
- PhD in chemical engineering or related technical field.
- Proficiency in Lean/Six Sigma methodologies and process optimization.
- Familiarity with regulatory compliance standards (FDA, GMP, ISO).
- Knowledge of statistical tools and data analysis software such as Minitab, JMP, R, Java, Python.
- A strong self-motivated team player with a proactive attitude is highly desired.
Requirements
- Bachelor’s or Master’s in chemical engineering or related technical field
- Minimum 5 years’ experience in process engineering, preferably in diagnostics, pharmaceuticals or biotechnology
- Strong problem-solving skills, including root cause analysis and data driven decision making
- Excellent teamwork and communication skills
- Knowledge of safe chemical and biological handling
- Ability to travel (<10%)
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan
- Employee assistance program
- Employee stock purchase plan
- Paid time off
- Paid holidays
Company overview
QuidelOrtho Corporation is a leading American in vitro diagnostics (IVD) company formed through the merger of Quidel Corporation and Ortho Clinical Diagnostics in 2022. Headquartered in San Diego, California, the company is publicly traded on Nasdaq under the symbol QDEL and generates over $3 billion in annual revenue. With more than 120 years of collective experience, QuidelOrtho ranks among the world's largest IVD providers, offering comprehensive diagnostic solutions across point-of-care settings, clinical laboratories, and transfusion medicine. The company's extensive product portfolio includes rapid antigen tests, molecular diagnostics, immunoassays, clinical chemistry systems, and blood bank solutions. QuidelOrtho gained significant recognition during the COVID-19 pandemic for developing the first FDA emergency use authorized rapid antigen test that delivers results in 15 minutes. The company's innovative technologies span infectious disease testing, women's health, cardiac biomarkers, autoimmune disorders, and transfusion medicine, serving healthcare providers worldwide with accurate, reliable diagnostic tools that improve patient outcomes across the healthcare continuum.