Senior Process Engineer, Diagnostics & Process Optimization

Ortho Clinical Diagnostics; City of Rochester (NY); On-site; USD 95,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Employee Stock Purchase Plan

Paid time off

Paid Holidays

Job summary

QuidelOrtho in Rochester, NY is seeking a Senior Process Engineer for assay development. You will design, develop, and optimize manufacturing processes ensuring quality, scalability, and capability of diagnostic products.

You will lead a multidisciplinary team, apply Lean/Six Sigma, perform risk analyses, and transfer processes to manufacturing with rigorous documentation and regulatory awareness.

Qualifications

• 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.

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.

Skills

Process engineering

Lean Six Sigma

Data analysis

Root cause analysis

Teamwork

Communication

Regulatory awareness

Education

Bachelor's or Master's in chemical engineering

PhD in chemical engineering or related field

Tools

Minitab

JMP

R

Java

Python

Job description

QuidelOrtho in Rochester, NY is seeking a Senior Process Engineer for assay development. You will design, develop, and optimize manufacturing processes ensuring quality, scalability, and capability of diagnostic products.

You will lead a multidisciplinary team, apply Lean/Six Sigma, perform risk analyses, and transfer processes to manufacturing with rigorous documentation and regulatory awareness.