Process Engineer

Job Responsibilities Design, optimize, and support pharmaceutical manufacturing processes to improve efficiency, quality, and compliance Provide day-to-day technical support for manufacturing operations, troubleshooting process and equipment issues Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to support production goals Evaluate and implement process improvements to enhance product quality, throughput, and operational performance Develop and maintain process documentation including batch records, SOPs, process flow diagrams, and technical reports Support technology transfer activities for new products and manufacturing processes Monitor process performance, analyze manufacturing data, and identify trends for continuous improvement opportunities Participate in Process Failure Mode and Effects Analysis (FMEA) activities to assess and mitigate process risks Assist with process validation activities including protocol development, execution, and report generation Support investigations related to deviations, non-conformances, and CAPA activities Apply Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP) to ensure regulatory compliance Evaluate and support implementation of new manufacturing equipment, technologies, and automation systems Partner with vendors and suppliers to review equipment specifications and process requirements Drive continuous improvement initiatives focused on safety, efficiency, waste reduction, and process reliability Support regulatory inspections and audits by providing technical expertise and process documentation Maintain accurate records and ensure data integrity for all engineering and manufacturing activities Qualifications Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field 3+ years of experience in pharmaceutical, biologics, medical device, or GMP-regulated manufacturing environments Strong knowledge of cGMP regulations, FDA requirements, and pharmaceutical manufacturing processes Experience with aseptic processing, sterile manufacturing, formulation, or fill-and-finish operations preferred Understanding of process validation, equipment qualification, and manufacturing quality systems Knowledge of process controls, instrumentation, and manufacturing equipment systems Experience supporting deviation investigations, CAPA activities, and change control processes Familiarity with risk management tools such as FMEA preferred Lean Six Sigma certification or continuous improvement experience preferred Strong analytical, troubleshooting, and problem-solving skills Excellent communication, teamwork, and technical writing abilities Ability to manage multiple priorities in a fast-paced manufacturing environment Proficiency with Microsoft Office, manufacturing systems, and data analysis tools preferred Ability to work independently and collaboratively within cross-functional teams #J-18808-Ljbffr Harba