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.
We are seeking a Process Engineer I to support manufacturing operations by assisting in the design, development, validation, and optimization of production processes. This intermediate experience role works under the guidance of senior engineers to ensure processes are efficient, safe, cost-effective, and compliant with quality and regulatory standards. Key responsibilities include supporting process and equipment validations (IQ/OQ/PQ), monitoring process performance, troubleshooting issues, and contributing to continuous improvement initiatives. The Process Engineer I collaborates with cross-functional teams including operations, quality, maintenance, and engineering to resolve issues, support new product introductions, and maintain validated states of equipment and processes
Responsibilities
Interfaces with Quality Assurance, Production, and Engineering departments on process requirements for new and current products.
Equipment qualification includes automation and computerized systems.
Writes and executes evaluation protocols for all processing steps (IQ/OQ/PQ)
Contributes to continuous improvement initiatives to enhance process efficiency, yield, and reliability.
Analyzes and interprets protocols to prepare additional documentation to support project.
Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
Prepares and edits all types of documentation (batch records, SOPs, protocols, summary reports, etc.)
Writes final reports and assures they are approved through proper channels
Trains Production and Quality Assurance personnel as required.
Attends Daily Meetings to provide updates as well as take away any actions.
Performs related duties as assigned
Perform other work-related duties as assigned
Required Skills:
Preferred Skills:
Internal Partners: Manufacturing, Chemistry Manufacturing, Engineering, Quality, R&D, and Regulatory
External Partners: OEM. MRO, Vendors, Service Contractors
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.
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.
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 $65,000 to $78,000 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.
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.