Production 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 Production 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, 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 role is located in Athens, Ohio.

The Responsibilities

• Identifies and owns process improvement initiatives related to production throughput, product yield, labor efficiency, product quality and OEE performance.

• Characterizes, optimizes, validates and completes ECOs for manufacturing processes to improve value stream performance.

• Lead CAPA and NCMR investigation processes (RCFA, 5 Why, Cause & Effects, DOE, Cause Mapping) and supports Quality Engineers in the execution of defined corrective actions.

• Coordinates failure investigation and deviation requests with Production Science & Quality Engineering team members.

• Supports the internal auditing of manufacturing processes by working with a cross-functional team to document findings and explore corrective actions.

• Oversees new product & process development for operations during the transfer to manufacturing.

• Tests and verifies new product manufacturing specifications per R&D requirements.

• Develops manufacturing processes, QC methods and demonstrates process feasibility using prototype equipment for new product launches.

• Determines if manufacturing scaleup and quality requirements are obtainable during new product transfer from R&D.

The Individual

Required:

• Bachelor's degree in engineering, life sciences, biotechnology or operations or an equivalent combination of education and experience.

• Experience with Quality Management Systems

• Direct experience with production planning and scheduling process

• Proven track record of project management

• Strong analytical capability and communication skills

• Knowledge of techniques for effectively maximizing manufacturing, testing & distribution process of finished goods

• Ability to be successful in influencing leaders, peers, and cross functional team members to work together to define issues, develop plans and implement actions on projects

• Ability to identify and correct complex problems by reviewing related information to develop and evaluate options and implement solutions

• Proven leadership skills with proven ability to facilitate effective cross-functional business improvement

Preferred:

• 3-5 years' experience in a manufacturing, production laboratory, or pharmaceutical industry environment

• Experience leading Kaizen events including elements such as standard work, cell design, process, and product 3P, Value-Analysis/Value Engineering, error-proofing, material flow, heijunka, and kanban in a manufacturing environment

• Familiarity with ISO and FDA standards

• Knowledge of ERP systems required, SAP preferred.

• Lean certification

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 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 50 lbs. onoccasion.Up to 50% of time in meetings, working with team in lab or manufacturing floor; 50% of the time at the desk on computer, walking, standing, or sitting extended periods of time, doing analytical work 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.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 .

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