Process Development Engineer - Pharmaceutical API

Placements24; LegKraal Gate; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Salary bonus

Health, dental, and vision insurance

Retirement plan

Professional growth opportunities

Cutting-edge API production

Job summary

Placements24 is seeking a Process Development Engineer to optimize and scale API manufacturing processes at their Mahikeng site. The role emphasizes robust, scalable chemical processes with strong background in chemical engineering, process chemistry, and scale-up within pharma settings.

The candidate should hold a Master’s or Ph.D. in a related field, with 5+ years in pharmaceutical process development, and be proficient in process safety and CPP design. A competitive package is offered.

Qualifications

• Master's or Ph.D. in Chemical Engineering, Organic Chemistry, or a related field.
• Minimum of 5 years of experience in pharmaceutical process development, API manufacturing.
• Knowledge of reaction engineering, unit operations, and scale-up principles.
• Experience with process safety assessments and regulatory requirements (ICH Q7).
• Strong analytical writing and communication skills.

Responsibilities

• Develop, optimize, and scale-up chemical processes for APIs from lab to pilot and commercial scales.
• Design and execute experiments to define CPPs and design spaces for API manufacturing.
• Conduct PHAs and implement safety measures to ensure safe operations.
• Troubleshoot process issues and improve yield, purity, efficiency, and reduce costs.
• Prepare detailed process development reports, scale-up justifications, and technology transfer documentation.
• Collaborate with researchers, analytical scientists, and manufacturing personnel for seamless transfer.

Skills

Reaction engineering

Unit operations

Scale-up

Problem solving

Education

Master's or Ph.D. in Chemical Engineering / Organic Chemistry

Tools

Process modeling software

Statistical analysis tools

Job description

About the Role

Our client is seeking a highly skilled Process Development Engineer to optimize and scale up Active Pharmaceutical Ingredient (API) manufacturing processes at their site in Mahikeng . You will play a crucial role in developing robust, efficient, and scalable chemical processes that ensure the quality and consistency of APIs. This position requires a strong background in chemical engineering, process chemistry, and scale-up principles within the pharmaceutical manufacturing environment.

Key Responsibilities

• Develop, optimize, and scale-up chemical processes for the synthesis of Active Pharmaceutical Ingredients (APIs) from laboratory to pilot and commercial scales.
• Design and execute experiments to define critical process parameters (CPPs) and establish design spaces for API manufacturing.
• Conduct process hazard analyses (PHAs) and implement safety measures to ensure safe operations.
• Troubleshoot process issues and implement improvements to enhance yield, purity, efficiency, and reduce costs.
• Prepare detailed process development reports, scale-up justifications, and technology transfer documentation.
• Collaborate closely with research chemists, analytical scientists, and manufacturing personnel to ensure seamless process transfer and implementation.

Requirements

• Master's or Ph.D. in Chemical Engineering, Organic Chemistry, or a related field.
• Minimum of 5 years of experience in pharmaceutical process development , with a focus on API manufacturing.
• In-depth knowledge of chemical reaction engineering, unit operations, and process scale-up principles.
• Experience with process safety assessments and understanding of regulatory requirements for API manufacturing (e.g., ICH Q7).
• Proficiency in using process modeling software and statistical analysis tools is a plus.
• Strong problem-solving skills, excellent technical writing abilities, and effective communication skills.

Benefits

• Excellent salary and bonus structure reflecting expertise and contribution.
• Comprehensive health, dental, and vision insurance.
• Retirement plan with employer matching.
• Opportunities for professional growth and development, including attending industry conferences.
• A dynamic and innovative manufacturing environment focused on cutting-edge API production.