HCG - Process Engineer Pharmaceutical Manufacturing

2 months ago


Philadelphia, United States Horizon Controls Group Full time

Job DescriptionWe are seeking a highly skilled and motivated Process Engineer to join our pharmaceutical manufacturing team. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and improving operational efficiency. This position requires a deep understanding of pharmaceutical manufacturing principles, process engineering, and regulatory compliance.Key ResponsibilitiesProcess Optimization:Develop, evaluate, and optimize manufacturing processes to enhance efficiency, quality, and cost-effectiveness.Identify and implement process improvements to reduce waste, increase yield, and improve overall production performance.Quality Assurance:Ensure all manufacturing processes comply with Good Manufacturing Practices (GMP), regulatory standards, and company quality policies.Conduct root cause analysis and corrective actions for process deviations and non-conformances.Technical Support:Provide technical support to production teams, troubleshoot process-related issues, and recommend solutions.Collaborate with R&D, Quality Control, and other departments to ensure smooth technology transfer and process validation.Documentation and Compliance:Prepare and maintain detailed documentation, including Standard Operating Procedures (SOPs), process flow diagrams, and validation protocols.Ensure compliance with all regulatory requirements, including FDA, EMA, and other relevant agencies.Project Management:Lead or participate in cross-functional project teams to develop and implement new processes, equipment, and technologies.Manage project timelines, budgets, and resources effectively to ensure successful project completion.Continuous Improvement:Drive continuous improvement initiatives by implementing Lean Manufacturing, Six Sigma, and other methodologies.Conduct regular process audits and reviews to identify areas for improvement and implement best practices.RequirementsEducation: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related field.Experience:Minimum of 5+ years of experience in process engineering within a pharmaceutical manufacturing environment.Experience with process optimization, scale-up, and validation in a GMP-regulated setting.Strong background working with Emerson DCS, SCADA, Siemens or Allen Bradley PLCs, MES, LIMS, BMS, ERPsExcellent communication and interpersonal skills to collaborate effectively with cross-functional teams.Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.Ability to manage multiple projects and prioritize tasks in a fast-paced environment.Preferred QualificationsCertified Lean Six Sigma Green Belt or Black Belt.



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