Process Development Engineer - Pharmaceutical Manufacturing

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

About the Role

Our client is seeking a highly skilled Process Development Engineer to optimize and scale up manufacturing processes for pharmaceutical products at their facility in Stellenbosch . This role is critical for ensuring efficient, robust, and compliant manufacturing operations. You will be involved in process design, validation, troubleshooting, and continuous improvement initiatives, working closely with manufacturing, engineering, and quality assurance teams. The ideal candidate has a strong engineering background with specific experience in pharmaceutical manufacturing environments and a passion for driving operational excellence.

Key Responsibilities

• Develop, optimize, and scale up pharmaceutical manufacturing processes, ensuring they are efficient, safe, and compliant with GMP.
• Design and execute process validation studies, including IQ, OQ, and PQ protocols.
• Troubleshoot and resolve manufacturing process issues, identifying root causes and implementing corrective and preventative actions (CAPAs).
• Collaborate with equipment engineers to ensure the selection and implementation of appropriate manufacturing technologies.
• Develop process control strategies and monitor critical process parameters (CPPs) to ensure consistent product quality.
• Author technical reports, process descriptions, and validation documentation for regulatory submissions and internal use.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or biotechnology industry.
• Strong understanding of GMP, process validation principles, and regulatory requirements for pharmaceutical manufacturing.
• Experience with various pharmaceutical manufacturing operations (e.g., granulation, tablet compression, sterile filling, lyophilization).
• Proficiency in process modeling, statistical analysis, and data interpretation.
• Excellent project management, problem-solving, and communication skills.

Benefits

• Competitive salary and performance-based bonus structure.
• Comprehensive health, dental, and vision insurance plans.
• Retirement savings plan with company contributions.
• Generous paid time off and opportunities for professional development.
• Exposure to advanced pharmaceutical manufacturing technologies in Stellenbosch .