Principal Pharmaceutical Process Engineer

About the Role Our client, a leading innovator in the pharmaceutical manufacturing sector, is seeking a highly experienced Principal Pharmaceutical Process Engineer to join their esteemed team in Welkom, Free State. This critical role will be responsible for designing, optimizing, and scaling up complex pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance. You will leverage your deep technical expertise in process engineering principles, GMP, and regulatory standards to drive continuous improvement initiatives. The successful candidate will lead cross-functional teams, mentor junior engineers, and provide strategic input on process development and validation activities. This position offers a unique opportunity to work with cutting-edge technologies and contribute to the production of essential medicines at our Welkom, Free State facility. Key Responsibilities Lead the design, development, and optimization of pharmaceutical manufacturing processes for solid dosage forms, sterile products, or biologics. Develop process flow diagrams (PFDs) and piping and instrumentation diagrams (P&IDs). Perform process hazard analyses (PHAs) and ensure safety considerations are integrated into process designs. Oversee process validation activities, including the development of protocols and reports, and execution of validation runs. Troubleshoot and resolve complex process-related issues encountered during manufacturing operations. Identify opportunities for process improvements to enhance yield, reduce costs, and improve efficiency. Collaborate closely with equipment vendors, engineering, quality assurance, and manufacturing teams. Mentor and guide junior process engineers, fostering their technical and professional development. Ensure all process designs and operations comply with GMP, FDA, EMA, and other relevant regulatory requirements. Stay current with emerging technologies and industry best practices in pharmaceutical manufacturing. Requirements Master's degree or Ph.D. in Chemical Engineering, Mechanical Engineering, or a related field. Minimum of 10 years of progressive experience in pharmaceutical process engineering, with a strong emphasis on process design, scale-up, and validation. Extensive knowledge of pharmaceutical manufacturing equipment (e.g., reactors, filtration systems, dryers, tablet presses, filling lines). In-depth understanding of GMP regulations, FDA guidelines, and industry standards. Proven experience with process simulation software and statistical process control (SPC). Demonstrated ability to lead cross-functional project teams and manage complex technical challenges. Strong analytical and problem-solving skills, with a data-driven approach to decision-making. Excellent communication, interpersonal, and presentation skills. Experience with aseptic processing or biologics manufacturing is a significant plus. Professional Engineer (PE) certification is desirable. Benefits Highly competitive salary package with performance-based incentives. Comprehensive health, dental, and vision insurance plans. Retirement savings plan and generous company contributions. Significant paid time off and holidays. Opportunities for advanced training, professional development, and conference attendance. Access to advanced manufacturing technologies at our Welkom, Free State site. Relocation assistance for eligible candidates. #J-18808-Ljbffr Placements24