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Process Engineer

1 month ago


Carlsbad CA USA, United States QuidelOrtho Full time
The Opportunity

QuidelOrtho is a world-leading in vitro diagnostics company that unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics. Our company is built on a culture that prioritizes team members' happiness, inspiration, and engagement. We strive to build meaningful connections with each other, believing that employee happiness and business success are linked.

We are transforming the power of diagnostics into a healthier future for all. Our team is dedicated to providing fast, accurate, and consistent testing where and when it's needed most.

The Role

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 monitoring current manufacturing processes, reducing variation, controlling/mitigating 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, and validating new or improved manufacturing processes and equipment.

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.
  • Lead/Support the evaluation of NCMR, CAPA, Failure Investigation, and Deviation requests arising from the Chemistry Manufacturing area of problematic manufacturing processes.
  • Lead/Support the audit of manufacturing processes, working with a cross-functional team. Participate in audits, document results, develop, and implement corrective action.
  • Assist the Process Engineering group in assigned deliverables from R&D development meetings as it relates to scale-up and current production capabilities in Mfg.
  • Execute all tasks in accordance with QuidelOrtho's Quality System and carry 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 a 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.
  • 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. The position requires the 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.