Sr. Process Engineer

Company: Ortho Clinical Diagnostics
Location: Raritan
Posted on: May 26, 2023

Job Description:

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

As we continue to grow as QuidelOrtho, we are seeking a Senior Process Engineer (CPV). As the Senior Process Engineer (CPV), you will support all areas of Engineering including equipment, instrument and process validation, equipment qualification (including continued process verification), manufacturing clean rooms, temperature control chambers and biological safety cabinets. Authors, reviews, executes and supports manufacturing environment validations and associated documentation.

This position is in Raritan, NJ.

The Responsibilities

• Reporting into the Manufacturing Engineering department, execute the CPV program (Continuous Process Verification) of critical instruments within the Manufacturing environment.
  
• Authors Validation documents, IQ OQ and PQ protocols and corresponding reports consistent with Standard Operating Procedures and regulatory requirements.
  
• Execute IQ, OQ and PQ protocols as required by Standard Operating Procedures.
  
• Execute pre-approved protocols as part of the Continued Process Verification (CPV) program and author associated reports.
  
• Pre-approved CPV protocol execution includes the set up and use of temperature mapping instruments for verifying temperature uniformity of controlled chambers.
  
• Work with and oversee external vendors and Manufacturing partners to manage the certification of Cleanrooms, HEPA filters, Laminar Flow Clean Air Devices, Biological Safety Cabinets and their associated components as required by Standard Operation Procedures and regulatory requirements.
  
• Partners with Quality Assurance department and Manufacturing in the investigation of protocol deviations and nonconformances (NC) to determine the impact on the product quality, the cause, and corrective actions to be taken.
  
• Leads root cause analysis investigations.
  
• Maintain inventory of critical HEPA filters within the Manufacturing space.
  
• Participate and present in internal and external audits which may include all areas of support and audit readiness tasks.
  
• Perform Engineering tasks per company needs, when required.
  
• Maintains a scheduled CPV program in an audit-ready state and willing to demonstrate program activities and review documentation for applicable auditors.
  
• Perform other work-related duties as assigned.
  The Individual
  
  Required:
  • Bachelor's Degree in any engineering or technical discipline
    
  • 7+ years of experience working in a similar industry as a Process, Validation or Quality Engineer
    
  • 2+ years of experience in the qualification and temperature mapping of temperature control chambers (i.e. Cold boxes, refrigerators, freezers, incubators, water baths, thaw rooms, autoclaves, and dry heat ovens)
    
  • 2+ years of experience with temperature mapping equipment (i.e. Kaye AVS Validator and Kaye RT ValProbes)
    
  • Travel: Up to 10% is required - Domestic
    Preferred:
    • Experience in Clean Room certifications; this would include knowledge and/or experience in environmental monitoring, room pressure differential requirements and HEPA filter requirements.
      
    • Experience in leading cross-functional teams, both technical and non-technical work.
      
    • Experience in the use of tools, multimeters or other diagnostic devices to aid in executing validation activities.
      
    • Ability to organize and present technical information with minimal assistance.
      The Key Working Relationships
      • Internal Partners: Coordination and collaboration with Manufacturing, Engineering, Quality Assurance and Product Support personnel for all aspects of the duties listed above.
        
      • External Partners: Communication with external suppliers, vendors and regulators as required. In the rare event contact with customers may be needed.
        The Work Environment
        • 50% of the work environment characteristics are representative of a typical office environment (working at the desk/computer, in cross-functional meetings, etc.)
          
        • 50% of the work environment characteristics are representative of a typical controlled manufacturing and cleanroom space (working in protective clothing, performing validations on equipment, using meters and instrumentation)
          
        • Travel: Up to 10% is required - Domestic
          
        • Some lifting, but not to exceed 50 pounds.
          
        • Must wear protective clothing and safety equipment, as required.
          
        • Ability to work in bio-hazard areas and clean rooms. Bio-hazard areas require the use of protective gear and on-going monitoring.
          
        • Some temperature mapping activities are performed in cold environments with the proper PPE.
          
        • Must be able to work off-shifts, weekends and extended hours as per equipment availability based on production schedules.
          
        • Manual dexterity for handling instruments, HMI screens and repetitive motions, sitting and standing for a long period of time.
          
        • Working conditions include sitting, standing, walking, working in cramped or awkward positions around equipment and in confined areas.
          
        • Physically able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
          
          
          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 $65,000 to $118,000 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.
          
          Equal 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 orthorecruiting@orthoclinicaldiagnostics.com
          
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Keywords: Ortho Clinical Diagnostics, Trenton , Sr. Process Engineer, Engineering , Raritan, New Jersey