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About the Role
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.
Responsibilities
- Design and optimize manufacturing processes for diagnostic reagents and related products.
- Lead a process improvement team, developing strategy and work plans 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 manufacturing operations and verify process capability against design requirements.
- Maintain accurate records in accordance with the QuidelOrtho Quality System.
- Maintain core expertise in surface modification, formulation, and coating.
- Maintain a safe working environment through proactive hazard and risk identification.
- Collaborate to help a team or work group achieve its goals.
- Perform other work-related duties as assigned.
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%).
- This position is not currently eligible for visa sponsorship.
Skills
- Surface modification
- Formulation
- Coating
- Lean/Six Sigma methodologies
- Process optimization
- Regulatory compliance standards (FDA, GMP, ISO)
- Statistical tools
- Data analysis software (Minitab, JMP, R, Java, Python)
Location
- Rochester, NY
Work Type
- Onsite
- Full-time
Experience Level
- Senior
Education Level
- Bachelor's
- Master's
- PhD
Salary/Compensations
- $95,000 to $105,000
- bonus eligible
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- Paid time off (including sick time)
- Paid Holidays
About the Company
- 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 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.
Equal 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 the 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 recruiting@quidelortho.com.