Process Engineer

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 Process Engineer provides direction and support to the manufacturing area utilizing structured problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery.  Key activities include, but are not limited to, monitoring of current manufacturing processes, reduction of variation, control/mitigation of process drift, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc.), validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing.

This position will be onsite in Carlsbad, CA.

The Responsibilities

• Lead/Support the design and optimization of manufacturing processes for diagnostic reagents and related products.

• Collaborate with cross functional teams to develop and improve process specifications.

• Characterize, optimize, validate and ECO manufacturing processes to improve efficiency and robustness of current processes.

• Leads / supports evaluation of NCMR, CAPA, Failure Investigation and Deviation requests arising from the Chemistry Manufacturing area of problematic manufacturing processes.

• Leads / supports the audit of manufacturing processes, working with a cross-functional team. Participates in audits, documents results develops and implements corrective action.

• Assists Process Engineering group in assigned deliverables from R&D development meetings as it relates to scale up and current production capabilities in Mfg.

• Executes all tasks in accordance with QuidelOrtho’s Quality System and carries out duties in compliance with established business policies.

• Translate Lean/Six Sigma principles to enhance product quality and increase manufacturing efficiency.

The Individual

Required:

• Bachelor’s degree in chemical engineering or related field.

• Minimum of 3 years’ experience in process engineering, with a background in the fields of diagnostics, biochemistry, or immunochemistry.

• Experience with regulatory compliance standards (e.g., FDA, ISO).

• Good problem-solving skills, including root cause analysis and data driven decision making.

• Excellent teamwork and communication skills.

• Knowledge of statistical tools and data analysis software such as Excel and Minitab.

• Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts)

Preferred:

• Experience in lateral flow technology preferred.

• Experience with Lean/ Six Sigma methodologies and process optimization.

The Key Working Relationships

Internal Partners:

Manufacturing, Chemistry Manufacturing, Engineering, Quality, R&D, and Regulatory

The Work Environment

The work environment characteristics are representative of both an office and laboratory environment and may include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Physical Demands

Position requires ability to lift up to 20 lbs. on occasion.  Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role.  Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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 - $120,000 annually. 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 Employment 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 their 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 [email protected].

#LI-HF1