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.