Senior Process Engineer Job at LVI Associates, Trenton, NJ

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  • LVI Associates
  • Trenton, NJ

Job Description

Senior Process Engineer

Role Overview:

This position involves delivering hands-on technical expertise to support the execution of four key manufacturing readiness assessments at designated production sites. The role includes on-site evaluations to determine preparedness levels and conducting process risk analyses (pFMEA) tailored to each location.

Key Responsibilities:

  • Conduct comprehensive assessments of operational readiness using process failure mode and effects analysis (pFMEA) methodologies.
  • Document and communicate findings, highlighting critical risks and proposing actionable recommendations.
  • Collaborate with cross-functional teams to address identified issues, perform root cause analysis, and implement corrective and preventive measures across equipment, systems, and workflows.
  • Apply in-depth knowledge of biologics manufacturing, particularly in monoclonal antibody production.
  • Interpret and utilize technical documentation such as engineering schematics, SOPs, and vendor manuals.
  • Manage assigned projects efficiently, ensuring timely delivery and alignment with broader engineering objectives.
  • Provide support to senior engineering staff on complex initiatives as needed.

Qualifications and Experience:

  • Bachelor's degree in Engineering or a related technical discipline.
  • 6-10 years of relevant industry experience, with a strong background in process validation and operational readiness.
  • Proven expertise in conducting pFMEAs and supporting Process Performance Qualification (PPQ) activities.
  • Experience working with cross-disciplinary teams including Manufacturing, Quality, Regulatory, and Process Development.
  • Comfortable navigating various production environments, including cleanrooms and controlled areas, with a clear understanding of product flow.
  • Solid grasp of validation principles across multiple domains, such as:
    • Chemical synthesis (small molecules)
    • Biologic drug manufacturing (e.g., monoclonal antibodies)
    • Cell and gene therapy
    • Aseptic fill/finish operations
    • Analytical testing labs
    • Computerized systems
    • Packaging processes
  • Strong communication skills, with the ability to present findings to senior leadership.
  • Advanced proficiency in Microsoft Project and general MS Office tools.
  • Familiarity with regulatory inspection processes and documentation standards.

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