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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