Process Development Engineer - API Manufacturing

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Hybrid work arrangement

Career growth

Job summary

Placements24 in Nelspruit is seeking a Process Development Engineer to optimize and scale up API manufacturing, ensuring safe, compliant, and cost-effective processes from lab to commercial scale.

You will lead experiments, collaborate across R&D, Manufacturing and Quality, and drive technology transfer with a strong focus on cGMP adherence and process validation.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering or related discipline.
• Minimum of 5 years of experience in process development or chemical engineering within pharmaceutical or fine chemical industry.
• Strong understanding of organic chemistry, reaction kinetics, and chemical engineering principles.
• Experience with process scale-up, optimization, and validation activities.
• Proficiency in process simulation software and data analysis tools.
• Knowledge of cGMP and regulatory requirements for API manufacturing is essential.

Responsibilities

• Develop, optimize, and scale-up chemical processes for API manufacturing from laboratory to pilot plant and commercial scales.
• Troubleshoot process deviations and implement corrective actions to ensure consistent product quality and yield.
• Conduct process hazard analyses (PHAs) and implement safety improvements.
• Design and execute experiments to understand process parameters and their impact on product attributes.
• Collaborate with R&D, Manufacturing, and Quality Control teams to ensure smooth technology transfer and validation.
• Author process development reports, validation protocols, and regulatory support documentation.

Skills

Process development

Chemical engineering

Data analysis

Education

Bachelor's or Master's in Chemical Engineering

Tools

Process simulation software

Data analysis tools

Job description

About the Role

Our client, a significant player in the pharmaceutical manufacturing sector located in Nelspruit , is seeking a skilled Process Development Engineer . This role is essential for optimizing and scaling up the manufacturing processes for Active Pharmaceutical Ingredients (APIs). You will be responsible for troubleshooting existing processes, developing new and improved manufacturing methods, and ensuring that all processes are safe, efficient, cost-effective, and compliant with regulatory standards. This position offers a unique opportunity for an experienced engineer to drive innovation in API production within Mpumalanga and contribute to the reliable supply of critical pharmaceutical components.

Key Responsibilities

• Develop, optimize, and scale-up chemical processes for API manufacturing from laboratory to pilot plant and commercial scales.
• Troubleshoot process deviations and implement corrective actions to ensure consistent product quality and yield.
• Conduct process hazard analyses (PHAs) and implement safety improvements.
• Design and execute experiments to understand process parameters and their impact on product attributes.
• Collaborate with R&D, Manufacturing, and Quality Control teams to ensure smooth technology transfer and validation.
• Author process development reports, validation protocols, and regulatory support documentation.

Requirements

• Bachelor's or Master's degree in Chemical Engineering or a related discipline.
• Minimum of 5 years of experience in process development or chemical engineering within the pharmaceutical or fine chemical industry.
• Strong understanding of organic chemistry, reaction kinetics, and chemical engineering principles.
• Experience with process scale-up, optimization, and validation activities.
• Proficiency in process simulation software and data analysis tools.
• Knowledge of cGMP and regulatory requirements for API manufacturing is essential.

Benefits

• Competitive salary commensurate with experience and qualifications.
• Comprehensive health, retirement, and other employee benefits.
• Potential for career growth and advancement within a growing organization.
• Opportunities to work on challenging and impactful projects in Nelspruit.
• A hybrid work arrangement to support work-life balance.