Senior Process Development Engineer - API Manufacturing

Placements24; Centurion; Hybrid; ZAR 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Benefits package

Hybrid role

Career development

Job summary

Placements24 seeks a Senior Process Development Engineer to join our Centurion, Gauteng, ZA facility in a hybrid role focused on optimizing and scaling API manufacturing processes. The candidate will lead lab-to-commercial scale development, collaborate across R&D, Manufacturing and QA, and drive process innovations within GMP guidelines.

The role requires a strong chemical engineering background, 6+ years in API process development, and proficiency with model-based tools (JMP, Aspen).

Qualifications

• B.Sc. or M.Sc. in Chemical Engineering or a related field.
• Minimum of 6 years of experience in process development, scale-up, and manufacturing of APIs or fine chemicals in a pharmaceutical or biopharmaceutical setting.
• Strong understanding of organic chemistry principles and reaction kinetics.
• Proficiency in process modeling software and statistical analysis tools (e.g., JMP, Aspen).
• Experience with process validation and technology transfer is essential.
• Knowledge of GMP, ICH guidelines, and safety regulations in pharmaceutical manufacturing.
• Excellent problem-solving, analytical, and project management skills.
• Effective communication and interpersonal skills, with the ability to work collaboratively.

Responsibilities

• Lead process development for APIs from lab to pilot and commercial scale.
• Optimize reaction conditions, purification, and isolation to improve yield and reduce costs.
• Design and execute experiments (DoE) to understand process parameters and CPPs.
• Develop process models and perform simulations to predict process performance and risks.
• Oversee technology transfer of processes to manufacturing sites and support initial runs.
• Troubleshoot API processes and implement effective solutions.
• Ensure GMP, safety and environmental regulations are followed.
• Prepare process development reports, batch records, and contribute to regulatory filings.
• Evaluate and implement new technologies to enhance API manufacturing capabilities.
• Collaborate with R&D, Analytical Development, Manufacturing and Quality Assurance.

Skills

Process development

Scale-up

GMP knowledge

Problem solving

Education

B.Sc./M.Sc. in Chemical Engineering

Tools

JMP

Aspen

Job description

About the Role

Our client, a dynamic player in the pharmaceutical sector, is seeking a Senior Process Development Engineer to join their operations in Centurion, Gauteng, ZA. This hybrid role focuses on optimizing and scaling up Active Pharmaceutical Ingredient (API) manufacturing processes. You will be instrumental in enhancing process efficiency, ensuring robustness, and driving innovation in API production. The ideal candidate will have a strong background in chemical engineering, process development, and scale-up within a GMP-regulated pharmaceutical environment. You will collaborate with research, manufacturing, and quality teams to bring new APIs from laboratory scale to commercial production. This position offers a unique opportunity to shape the manufacturing processes of critical pharmaceutical ingredients.

Key Responsibilities

• Lead process development activities for new and existing APIs, from lab-scale to pilot and commercial scale.
• Optimize reaction conditions, purification methods, and isolation techniques to improve yield, purity, and reduce costs.
• Design and execute experiments (DoE) to understand process parameters and establish critical process controls (CPPs).
• Develop process models and perform simulations to predict process performance and identify potential risks.
• Oversee technology transfer of processes to manufacturing sites, providing technical support during initial runs.
• Troubleshoot manufacturing issues related to API processes and implement effective solutions.
• Ensure all process development activities comply with GMP, safety, and environmental regulations.
• Prepare detailed process development reports, batch records, and contribute to regulatory filings.
• Evaluate and implement new technologies to enhance API manufacturing capabilities.
• Collaborate with cross-functional teams including R&D, Analytical Development, Manufacturing, and Quality Assurance.

Requirements

• B.Sc. or M.Sc. in Chemical Engineering or a related field.
• Minimum of 6 years of experience in process development, scale-up, and manufacturing of APIs or fine chemicals in a pharmaceutical or biopharmaceutical setting.
• Strong understanding of organic chemistry principles and reaction kinetics.
• Proficiency in process modeling software and statistical analysis tools (e.g., JMP, Aspen).
• Experience with process validation and technology transfer is essential.
• Knowledge of GMP, ICH guidelines, and safety regulations in pharmaceutical manufacturing.
• Excellent problem-solving, analytical, and project management skills.
• Effective communication and interpersonal skills, with the ability to work collaboratively.
• Ability to work effectively both on-site in Centurion, Gauteng, ZA and remotely for specific tasks.

Benefits

• This role comes with a competitive salary and a comprehensive benefits package.
• You will have the opportunity to work with a highly respected pharmaceutical company on exciting development projects.
• Gain exposure to a wide range of API manufacturing technologies and processes.
• Enjoy opportunities for professional development and career advancement.
• Contribute to the production of essential medicines.
• The hybrid nature of the role offers flexibility while ensuring crucial on-site engagement for hands-on process development and oversight at our Centurion, Gauteng, ZA facility.
• Be part of a forward-thinking team dedicated to innovation and operational excellence.