Technical Operations Process Specialist

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 Technical Operations Process Engineer supports the development, optimization, and implementation of Chemistry manufacturing processes to improve scalability, yield, and cost-effectiveness while ensuring compliance with regulatory requirements. The position involves hands-on preparation of chemistries, data collection and analysis, documentation, and collaboration with senior staff to drive process improvements and operational excellence in manufacturing.

This position will be located onsite in San Diego, CA.

• Investigate and resolve manufacturing issues across chemistry and production processes

• Develop / characterize testing or performance specification for raw materials and manufacturing processes

• Prepare chemistries, including particle dye loading, antibody/drug derivative modification, purification, and formulation

• Collect, format, and analyze data using moderate to complex instrumentation.

• Collaborate with senior staff on experimentation, design of experiments (DOE), and generation of technical reports with data analysis and recommendations

• Draft, revise, and maintain manufacturing and process documentation in compliance with quality and regulatory standards

• Draft and execution of engineering and validation protocols.

• Monitor production activities, analyze in-process performance, and recommend improvements

Required:

• Bachelor's degree in Chemistry, Engineering, other scientific discipline or equivalent

• Minimum of 3 years of related experience within GMP manufacturing environment

• Strong knowledge of process optimization, scale up and standardization.

• Ability to develop new processes and set specifications

• Working knowledge of experimental design and statistical analysis

• Knowledgeable in troubleshooting and optimization of reagents and processes

• Demonstrated ability to carry out experiments following established guidelines and summarize results accurately

• Demonstrate problem-solving and troubleshooting skills

• Demonstrates ability to consistently meet proposed objective timelines, applying competent use of project planning and project management skills

• Strong verbal and written communication skills

• Organized and detail oriented

• Ability to work in a team environment

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies

• Ability to travel up to 25%

• This position is not currently eligible for visa sponsorship.

Preferred:

• Knowledge of related quality system regulations and processes

• Knowledgeable in the use of various database and data analysis programs (Power BI, JMP, Mini Tab, Microsoft Access)

• Knowledgeable in Good lab practices and safety techniques

• Proficient with complex lab equipment and procedures

• Knowledge and ability to use MS Office and other manufacturing systems

• Six Sigma Black Belt preferred

Internal Partners:

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

The work environment characteristics are representative of both an office and laboratory/manufacturing environments 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.

Position requires ability to lift up to 20 lbs. on occasion. Up to 75% of time on manufacturing floor 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 $79,000 - $106,000 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.

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 recruiting@quidelortho.com.

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