Process Development Engineer - Pharmaceutical API Manufacturing

Placements24; Mtubatuba Local Municipality; Hybrid; ZAR 850,000 - 1,200,000; Full time

Benefits offered by this job

Relocation package available

International training opportunities

Cutting-edge facilities

Sustainability focus

Job summary

Placements24 is seeking a Process Development Engineer for our pharmaceutical client in Richards Bay, KwaZulu-Natal. The role focuses on developing, optimizing, and scaling API manufacturing processes with emphasis on safety, quality, and regulatory compliance.

You will collaborate with R&D, manufacturing, and QA teams, design scalable synthesis routes, perform lab and pilot studies, and drive process improvements in a state-of-the-art facility.

Qualifications

• Bachelor's or Master's in Chemical Engineering, Chemistry, or related field; PhD is a plus.
• Minimum 5 years in process development and scale-up in pharma or fine chemicals.
• Strong knowledge of organic synthesis, kinetics, thermodynamics, and separations.
• Experience with GMP and regulatory API manufacturing.

Responsibilities

• Design, develop, and optimize API synthesis routes and processes.
• Run lab-scale and pilot-scale studies to validate new processes.
• Perform PHAs and implement safety measures.
• Use process modeling to predict and optimize performance.
• Develop analytical methods for process monitoring and QC.
• Collaborate with R&D, manufacturing, and QA for tech transfers.
• Troubleshoot scale-up issues and support commercial manufacturing.
• Prepare technical reports and regulatory documentation.
• Ensure compliance with EH&S regulations.

Skills

Process development

Scale-up

Pharmaceutical manufacturing

Process simulation

GMP knowledge

Project management

Team collaboration

Education

BSc/MSc in Chemical Engineering or Chemistry

PhD is a plus

Tools

Aspen Plus

Chemcad

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is seeking an innovative Process Development Engineer to join their operations in Richards Bay, KwaZulu-Natal. This critical role focuses on developing, optimizing, and scaling up chemical processes for the manufacturing of Active Pharmaceutical Ingredients (APIs). The engineer will be responsible for improving process efficiency, ensuring safety, and maintaining the highest quality standards. This position offers a significant opportunity to contribute to the advancement of pharmaceutical manufacturing technology and work on the production of essential medicines. The successful candidate will collaborate with a team of experienced scientists and engineers in a state-of-the-art facility, driving innovation in chemical synthesis and process engineering. We are looking for a proactive individual who is passionate about process improvement and chemical engineering excellence.

Key Responsibilities

• Design, develop, and optimize chemical synthesis routes and manufacturing processes for APIs.
• Conduct laboratory-scale experiments and pilot plant studies to validate new processes and improve existing ones.
• Perform process hazard analyses (PHAs) and implement safety measures to ensure a safe working environment.
• Utilize process modeling and simulation tools to predict and optimize process performance.
• Develop and validate analytical methods for process monitoring and product quality control.
• Collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure seamless process transfer and implementation.
• Troubleshoot and resolve process-related issues during scale-up and commercial manufacturing.
• Prepare detailed technical reports, process descriptions, and documentation for regulatory submissions.
• Ensure compliance with all relevant environmental, health, and safety (EHS) regulations.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Chemistry, or a related field. A PhD is a plus.
• Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or fine chemical industry.
• Strong understanding of organic synthesis, reaction kinetics, thermodynamics, and separation processes.
• Proven experience with process safety assessments and risk management.
• Proficiency in process simulation software (e.g., Aspen Plus, Chemcad) is highly desirable.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong project management and communication skills.
• Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements for API manufacturing.
• Must be able to work effectively in a highly technical and collaborative environment in Richards Bay, KwaZulu-Natal.

Benefits

• Highly competitive salary and bonus structure.
• Comprehensive medical, retirement, and life insurance benefits.
• Generous annual leave allowance.
• Opportunities for international training and professional growth.
• Relocation package available for qualified candidates.
• Access to cutting-edge research and development facilities.
• A dynamic work environment with a focus on innovation and sustainability.