Senior Process Engineer
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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