Process Development Engineer - Pharmaceutical Manufacturing

Placements24; Benoni; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary package

Health, disability, and life insurance

Pension plan

Generous paid time off

Professional growth opportunities

Access to cutting-edge manufacturing技

Job summary

Placements24 in Benoni, Gauteng, seeks a Process Development Engineer to optimize manufacturing processes, scale up techniques, and drive technology transfer to production.

The role requires hands-on work in lab and pilot plant settings and a strong background in chemical, mechanical, or pharmaceutical engineering with cGMP exposure.

Qualifications

• Bachelor's or master's degree in Chemical, Mechanical, or Pharmaceutical Engineering.
• Minimum of 5 years in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
• Experience with process validation, DOE (Design of Experiments), and statistical process control (SPC).
• Knowledge of cGMP, FDA, and EMA regulations related to pharmaceutical manufacturing.

Responsibilities

• Design and optimize pharmaceutical manufacturing processes across solid dosage forms, sterile products, or biologics.
• Conduct experiments and trials in laboratory and pilot plant settings to evaluate process parameters and scalability.
• Analyze process data, identify areas for improvement, and implement solutions to enhance efficiency and yield.
• Develop process models and simulations to predict process performance and identify potential risks.
• Lead technology transfer activities from R&D/pilot scale to commercial manufacturing.
• Develop and execute process validation protocols and reports.
• Troubleshoot manufacturing process deviations and implement corrective actions.
• Collaborate with equipment engineers to ensure appropriate design, installation, and qualification of manufacturing equipment.
• Ensure all process development activities comply with cGMP, safety, and environmental regulations.
• Prepare technical reports, documentation, and presentations for internal stakeholders and regulatory submissions.

Education

Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or Pharmaceutical Engineering

Tools

Aspen Plus

Job description

About the Role

Our client is seeking a highly skilled and innovative Process Development Engineer to contribute to their advanced pharmaceutical manufacturing operations in Benoni, Gauteng . This role is crucial for optimizing existing manufacturing processes and developing new ones to enhance efficiency, yield, and product quality. You will be instrumental in applying engineering principles and scientific knowledge to solve complex manufacturing challenges. The ideal candidate possesses a strong background in chemical or mechanical engineering with specific experience in pharmaceutical process development and scale-up. This position requires hands-on involvement in pilot plant operations and technology transfer to commercial manufacturing. You will work collaboratively with production, quality control, and R&D teams to drive continuous improvement and ensure robust, scalable manufacturing processes. This is an exceptional opportunity for an engineer passionate about advancing pharmaceutical manufacturing technologies within a dynamic and growing organization committed to producing high-quality medicines. Your expertise will directly impact the efficiency and reliability of our production lines, ensuring consistent product availability for patients worldwide.

Key Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes, including solid dosage forms, sterile products, or biologics.
• Conduct experiments and trials in laboratory and pilot plant settings to evaluate process parameters and scalability.
• Analyze process data, identify areas for improvement, and implement solutions to enhance efficiency and yield.
• Develop process models and simulations to predict process performance and identify potential risks.
• Lead technology transfer activities from R&D/pilot scale to commercial manufacturing.
• Develop and execute process validation protocols and reports.
• Troubleshoot manufacturing process deviations and implement corrective actions.
• Collaborate with equipment engineers to ensure appropriate design, installation, and qualification of manufacturing equipment.
• Ensure all process development activities comply with cGMP, safety, and environmental regulations.
• Prepare technical reports, documentation, and presentations for internal stakeholders and regulatory submissions.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or Pharmaceutical Engineering.
• Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
• Strong understanding of unit operations relevant to pharmaceutical manufacturing.
• Experience with process validation, DOE (Design of Experiments), and statistical process control (SPC).
• Knowledge of cGMP, FDA, and EMA regulations related to pharmaceutical manufacturing.
• Proficiency in process simulation software (e.g., Aspen Plus) and data analysis tools.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong project management and communication skills.
• Ability to work effectively in a multidisciplinary team environment.
• Hands-on experience with pilot plant operations and equipment is highly desirable.

Benefits

• Competitive salary package with performance-related bonuses.
• Comprehensive health, disability, and life insurance benefits.
• Pension fund and retirement savings plan.
• Generous paid time off and holiday leave.
• Opportunities for professional growth and advanced training.
• Access to cutting-edge manufacturing technologies and facilities.
• Collaborative work environment focused on innovation.
• Employee wellness initiatives and support resources.
• Clear career progression pathways.
• Direct impact on the production of essential medicines.