Pharma Process Development Engineer – Scale-Up & GMP

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

Benefits offered by this job

Salary + bonus

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Placements24 in Stellenbosch seeks a Process Development Engineer to optimize and scale up pharmaceutical manufacturing processes, ensuring GMP compliance and robust operations. You will design validation studies, troubleshoot issues, and collaborate with QA, engineering, and manufacturing teams to drive continuous improvement.

The role requires a strong engineering background with pharma manufacturing experience and a commitment to regulatory readiness and operational excellence.

Qualifications

• Bachelor's or Master's degree in Chemical or Mechanical Engineering.
• Minimum 5 years of process development and scale-up experience in pharma/biotech.
• Strong GMP and regulatory knowledge.
• Experience with granulation, tablet compression, sterile filling, lyophilization.
• Proficient in process modeling and data interpretation.
• Excellent project management and communication skills.

Responsibilities

• Develop and optimize manufacturing processes for pharma products.
• Design and execute IQ/OQ/PQ validation studies.
• Troubleshoot process issues and implement CAPAs.
• Collaborate with equipment engineers on technology choices.
• Develop CPP monitoring and control strategies.
• Prepare technical reports and validation documentation.

Skills

Process development

Scale-up

GMP

Statistical analysis

Data interpretation

Project management

Communication

Education

Bachelors or Masters in Engineering

Job description

Placements24 in Stellenbosch seeks a Process Development Engineer to optimize and scale up pharmaceutical manufacturing processes, ensuring GMP compliance and robust operations. You will design validation studies, troubleshoot issues, and collaborate with QA, engineering, and manufacturing teams to drive continuous improvement.

The role requires a strong engineering background with pharma manufacturing experience and a commitment to regulatory readiness and operational excellence.