HCG Process Engineer

2 months ago


Raleigh, 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 Responsibilities Process 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.Requirements Education: 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, ERPs Excellent 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 Qualifications Certified Lean Six Sigma Green Belt or Black Belt.


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