Senior Process Engineer (R&D)

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

Job summary

QuidelOrtho in Rochester, NY seeks a Senior Process Engineer to lead design, development and optimization of manufacturing processes for diagnostic products. You will collaborate with scientists, engineers and QA to ensure quality, scalability and process capability while acting as a technical project leader and performing lab work.

This is an onsite full-time role requiring 5+ years in diagnostics/pharma/biotech process engineering, strong problem solving, teamwork, and data-driven decision

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.
• Ability to travel (<10%).
• This position is not currently eligible for visa sponsorship.

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

Root cause analysis

Data-driven decisions

Teamwork

Communication

Safe handling

Travel up to 10%

Education

Bachelor's or Master's in chemical engineering or related technical field

Tools

Minitab

JMP

R

Java

Python

Job description

The Opportunity

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.

The Role

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Process Engineer supporting assay development. We are seeking a talented Senior Process Engineer in Rochester, NY to join us in our mission to create world class diagnostic solutions. 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.

The 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.

The Individual

Required

• 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%).
• This position is not currently eligible for visa sponsorship.

Preferred

• 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.

The Key Working Relationships

Internal Partners

• Collaborate with cross functional teams to develop and improve process specifications and quality standards.
• Train and mentor junior engineers and scientists, fostering a culture of continuous improvement and knowledge sharing.
• Interface with Operations and Tech Transfer colleagues to ensure processes are implemented seamlessly.

External Partners

• Work with raw material and equipment suppliers to ensure all materials are suitable for the intended use.

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together - Collaborate intentionally, grow as a team
• Make It Happen - Focus on priorities, embrace continuous improvement
• Commit to Service - Cultivate a service mindset
• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

This position may require:

• Sitting, frequently (34% to 66%)
• Standing, occasionally (up to 33%)
• Bending, rarely (<10%)
• Walking, occasionally (up to 33%)
• Lifting/ carrying items up to 20 Lbs., occasionally (up to 33%)
• Pushing/ pulling, rarely (<10%)
• Presenting in small groups, occasionally (up to 33%)

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $95,000 to $105,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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 [e-mail].