Process Development Engineer - API Manufacturing

Placements24; Bloemfontein; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Bonuses based on performance

Health and retirement benefits

Hybrid work arrangement

Job summary

You will design experiments, drive process improvements, perform tech transfer, and ensure documentation and compliance across R&D, manufacturing, and QA teams in a hybrid setting.

Qualifications

• B.Eng. or M.Eng. in Chemical Engineering or related discipline.
• Minimum 5 years in process development or chemical engineering in pharma or fine chemicals.
• Proven API manufacturing experience including synthesis, purification, isolation.
• Strong knowledge of reaction kinetics, thermodynamics, mass transfer.
• Hands-on scale-up and technology transfer to manufacturing.
• Familiarity with GMP and quality systems in pharmaceutical manufacturing.
• Proficiency in process simulation software (e.g., Aspen Plus, CHEMCAD) is advantageous.

Responsibilities

• Develop, optimize, and scale-up chemical processes for API manufacturing.
• Design and execute experiments to study process parameters and improve yields and purity.
• Conduct process validation studies and generate validation reports.
• Troubleshoot deviations and implement CAPAs.
• Collaborate across R&D, manufacturing, QA/QC for tech transfer and process implementation.

Skills

Process development

Chemical engineering

GMP compliance

Analytical skills

Project management

Education

B.Eng./M.Eng. Chemical Engineering

Tools

Aspen Plus

CHEMCAD

Job description

About the Role

Our client, a dynamic player in the pharmaceutical manufacturing industry, is seeking an experienced Process Development Engineer for their facility in Welkom. This hybrid role focuses on the optimization, scale-up, and validation of manufacturing processes for Active Pharmaceutical Ingredients (APIs). You will be instrumental in enhancing process efficiency, ensuring product quality, and driving innovation in API production. This position requires a strong foundation in chemical engineering principles applied within a GMP-regulated environment. The hybrid nature of the role allows for focused lab and plant work, coupled with the flexibility of remote collaboration and analysis. Join a dedicated team committed to excellence in pharmaceutical manufacturing.

Key Responsibilities

• Develop, optimize, and scale-up chemical processes for API manufacturing, ensuring robustness and reproducibility.
• Design and execute experiments to investigate process parameters, identify critical process controls, and improve yields and purity.
• Conduct process validation studies and generate comprehensive validation reports.
• Troubleshoot manufacturing process deviations and implement corrective and preventive actions (CAPAs).
• Collaborate with R&D, manufacturing, quality control, and quality assurance teams to ensure seamless technology transfer and process implementation.
• Develop process models and conduct simulations to predict process performance and identify optimization opportunities.
• Ensure all process development activities comply with current Good Manufacturing Practices (cGMP) and safety regulations.
• Prepare clear and detailed technical documentation, including process descriptions, SOPs, and batch records.
• Evaluate and implement new technologies and equipment to improve manufacturing capabilities.
• Contribute to hazard assessments and risk analyses for new and existing processes.

Requirements

• B.Eng. or M.Eng. 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.
• Proven experience in API manufacturing processes, including synthesis, purification, and isolation.
• Strong understanding of reaction kinetics, thermodynamics, and mass transfer principles.
• Hands-on experience with scale-up studies and technology transfer to manufacturing.
• Familiarity with GMP regulations and quality systems in pharmaceutical manufacturing.
• Proficiency in process simulation software (e.g., Aspen Plus, CHEMCAD) is advantageous.
• Excellent analytical, problem-solving, and project management skills.
• Ability to work effectively in a hybrid setting, balancing on-site and remote responsibilities in Welkom.
• Strong communication and interpersonal skills for effective cross-functional collaboration.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits package.
• Retirement fund contributions.
• Paid annual leave and public holidays.
• Hybrid work arrangement offering flexibility.
• Professional development opportunities and ongoing training.
• Access to advanced process development labs and pilot plant facilities.
• A stimulating work environment focused on continuous improvement and innovation.
• Opportunities for career growth within a reputable pharmaceutical company.
• Be part of a team driving the production of essential medicines.