About the Role
Our client seeks a skilled and experienced Process Development Engineer to join their innovative pharmaceutical manufacturing team near Paarl, Western Cape. This hybrid role combines strategic remote planning and analysis with essential on-site engineering, validation, and troubleshooting activities. You will be responsible for designing, developing, optimizing, and scaling up manufacturing processes for new and existing pharmaceutical products, ensuring efficiency, quality, and compliance with regulatory standards. The ideal candidate will possess a strong engineering background, a deep understanding of pharmaceutical manufacturing principles, and a proactive approach to problem-solving. This position offers a unique opportunity to contribute to the advancement of pharmaceutical production technologies and to work within a company dedicated to improving global health. You will play a critical role in ensuring the robust and efficient production of vital medicines.
Key Responsibilities
- Design, develop, and optimize chemical and manufacturing processes for pharmaceutical products.
- Scale-up processes from laboratory bench to pilot plant and commercial manufacturing scales.
- Conduct process validation studies and prepare validation reports.
- Identify and implement process improvements to enhance yield, reduce costs, and improve efficiency.
- Troubleshoot manufacturing process issues and implement effective corrective and preventive actions (CAPAs).
- Develop and maintain detailed process documentation, including PFDs, P&IDs, and SOPs.
- Collaborate with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure seamless technology transfer and process implementation.
- Evaluate and select new process equipment and technologies.
- Ensure all processes comply with cGMP, EHS, and other relevant regulatory requirements.
- Provide technical support and training to manufacturing personnel.
Requirements
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
- Minimum of 5 years of experience in process development and/or manufacturing within the pharmaceutical industry.
- Strong understanding of process engineering principles, including mass transfer, heat transfer, and reaction kinetics.
- Hands-on experience with process validation, scale-up, and technology transfer.
- Proficiency in process simulation software and statistical analysis tools.
- Knowledge of cGMP regulations and pharmaceutical manufacturing environments.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong communication and interpersonal skills, with the ability to work effectively in a hybrid team setting.
- Must be able to perform on-site duties as required near Paarl , balancing with remote strategic tasks.
- Experience with aseptic processing or solid dosage form manufacturing is a plus.
Benefits
- Our client provides a competitive salary and a comprehensive benefits package.
- This includes medical aid, a retirement fund, performance bonuses, and opportunities for professional development and further education.
- The hybrid work model offers a balance between remote work and on-site engagement.
- Employees benefit from working in a modern facility with advanced manufacturing capabilities and a collaborative team environment.
- We are dedicated to fostering innovation and excellence in pharmaceutical manufacturing.
- Join our team and make a tangible impact on the production of essential medicines in the Western Cape .