Bioprocess Engineer - Pharmaceutical Manufacturing

Placements24; Riverton (UT); On-site; USD 54,000 - 79,000; Full time

Job summary

Placements24 seeks a Bioprocess Engineer for a cutting-edge biopharmaceutical manufacturing facility in Upington, Northern Cape. The role focuses on developing, optimizing, and scaling bioprocesses to produce high-quality therapeutic products.

You will lead upstream and downstream process development, drive scale-up activities from lab to production scales, and ensure documentation and validation comply with GMP and global regulatory standards.

Qualifications

• Design, develop, and optimize upstream (cell culture, microbial) and downstream (purification) bioprocesses for therapeutic products.
• Lead scale-up activities from lab to pilot and commercial scales.
• Develop and execute process validation protocols and generate reports in compliance with regulatory requirements (GMP, FDA, EMA).
• Troubleshoot process deviations and implement CAPA actions.
• Author and review technical documents including process descriptions and batch records.

Responsibilities

• Design, develop, and optimize upstream (cell culture, microbial fermentation) and downstream (purification) bioprocesses for therapeutic products.
• Lead scale-up activities from laboratory bench to pilot and commercial manufacturing scales.
• Develop and execute process validation protocols and generate reports in compliance with regulatory requirements (GMP, FDA, EMA).
• Troubleshoot process deviations and implement effective CAPA actions.
• Author and review technical documents, including process descriptions and batch records.

Skills

Bioprocess Engineering

Process Scale-Up

GMP Compliance

Tools

Cell Culture

Downstream Purification

Job description

About the Role

Our client, a pioneering biopharmaceutical company, is seeking a highly skilled and innovative Bioprocess Engineer to join their state-of-the-art manufacturing facility in Upington, Northern Cape. This critical role will focus on the development, optimization, and scale-up of biopharmaceutical manufacturing processes, ensuring the production of high-quality therapeutic products. The Bioprocess Engineer will be instrumental in designing and implementing robust upstream and downstream processes, troubleshooting operational challenges, and driving continuous improvement initiatives. This is an exciting opportunity for a talented engineer passionate about biomanufacturing to contribute to cutting-edge advancements in a growing field. Be a part of our dedicated team in Upington, shaping the future of biopharmaceuticals.

Key Responsibilities

• Design, develop, and optimize upstream (cell culture, microbial fermentation) and downstream (purification) bioprocesses for therapeutic proteins and other biological products.
• Lead scale-up activities from laboratory bench to pilot and commercial manufacturing scales.
• Develop and execute process validation protocols and generate reports in compliance with regulatory requirements (e.g., GMP, FDA, EMA).
• Troubleshoot process deviations and implement effective corrective and preventive actions (CAPA).
• Author and review technical documents, including process descriptions, batch records, and technology