Technical Operations 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 Role

The Technical Operations Process Engineer provides direction and support to the manufacturing area utilizing industry standard 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, development / definition of new process specifications, reduction of variation, 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, SOPs, etc.), validation of new or improved manufacturing processes / equipment and integrating new products from R&D into manufacturing.

This position will be located onsite in Athens, Ohio.

The Responsibilities

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

• Assist / Lead in multi-site technical transfer activities from R&D to Operations

• Develop / characterize material property specification for critical to quality raw materials

• Assists Supply Chain and Supplier Quality Engineering in qualifying new vendor’s for established raw materials

• Design, characterize and validate new processes or equipment to improve manufacturability

• Leads / supports evaluation of NC’s, CAPA’s, Failure Investigation and Deviation arising from  Manufacturing for complex manufacturing processes.

• Owns and executes assigned deliverables from R&D development meetings as it relates to scale up and current production capabilities in Mfg.

• Develop / characterize testing or performance specification for manufacturing processes

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

• Liaison for contract manufactures

• Establishment as subject matter expert for all manufacturing processes at the Athen’s facility

• Multi-site travel will be required, up to 25%.

• Perform other duties & projects as assigned.

The Individual

Required:

• BA/BS in engineering or related field and 3-5 years’ experience within a cGMP manufacturing environment or equivalent.

• Strong analytical and problem-solving skills

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

• Well versed in time management and ability to manage multiple projects at a time

• Good organizational skills, and the ability to manage multiple tasks

• Ability to execute and analyze Desing of Experiments (DOE’s) and make data driven decisions independently

• Ability to develop new processes and set specifications

• Characterize materials and set specifications

• Troubleshoot problems

• Write and execute associated validations

• Ability to work within cross-functional teams / sites

• Good communication skills, written and verbal.

• Knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.).

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

• Knowledge of related quality system regulations and processes

• Appropriate computer skills (e-mail, word processing, graphing software)

• Must be able to resolve complex technical problems independently and collaboratively in a timely manner to minimize production schedule disruptions

• Must possess ability to develop experimental plan and execute associated activities per communicated timelines

• This position is not currently eligible for visa sponsorship. 

Preferred:

• Six Sigma Black belt preferred

The Key Working Relationships

Internal Partners:

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

The Work Environment

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.

Physical Demands

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.

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].

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