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