Process Development Engineer - Biologics

Placements24; Pretoria; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Relocation assistance

Professional development

Job summary

Placements24 in Pretoria is seeking a Process Development Engineer specializing in biologics manufacturing to design, optimize, and scale up complex production processes in a state-of-the-art facility.

You will lead experiments, validate process controls, and collaborate with R&D, manufacturing, QA, and regulatory teams to ensure quality and compliance with regulatory standards.

Qualifications

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or related field.
• Minimum of 4 years of experience in process development for biologics manufacturing.
• Strong understanding of cell culture, fermentation, purification techniques (e.g., chromatography, filtration), and aseptic processing.
• Experience with process modeling, statistical analysis, and Design of Experiments (DoE).
• Familiarity with GMP regulations and relevant pharmaceutical industry standards for biologics.

Responsibilities

• Develop, optimize, and scale up manufacturing processes for biologic drug substances, including upstream and downstream operations.
• Design and execute experiments to characterize process parameters and establish control strategies.
• Troubleshoot manufacturing process deviations and implement effective corrective and preventive actions (CAPAs).
• Prepare process validation protocols and reports, ensuring compliance with regulatory guidelines.
• Collaborate with cross-functional teams including R&D, manufacturing operations, quality assurance, and regulatory affairs.

Skills

Process development

Biologics manufacturing

DoE

Statistical analysis

Cell culture

Fermentation

Aseptic processing

GMP knowledge

Education

Master's or Ph.D. in Chemical/Biochemical Engineering or related field

Tools

Chromatography

Filtration

Aseptic processing

Job description

About the Role

Our client is seeking a talented Process Development Engineer specializing in biologics manufacturing to join their dynamic team in Pretoria . This role is integral to optimizing and scaling up manufacturing processes for complex biologic drugs. You will be responsible for designing, implementing, and validating robust and efficient production processes that meet stringent quality and regulatory standards. This is a fantastic opportunity for an engineer passionate about pharmaceutical manufacturing to contribute to bringing life-saving biologics to patients, working within a state-of-the-art facility in Gauteng .

Key Responsibilities

• Develop, optimize, and scale up manufacturing processes for biologic drug substances, including upstream and downstream operations.
• Design and execute experiments to characterize process parameters and establish control strategies.
• Troubleshoot manufacturing process deviations and implement effective corrective and preventive actions (CAPAs).
• Prepare process validation protocols and reports, ensuring compliance with regulatory guidelines.
• Collaborate with cross-functional teams including R&D, manufacturing operations, quality assurance, and regulatory affairs.

Requirements

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related field.
• Minimum of 4 years of experience in process development for biologics manufacturing .
• Strong understanding of cell culture, fermentation, purification techniques (e.g., chromatography, filtration), and aseptic processing.
• Experience with process modeling, statistical analysis, and Design of Experiments (DoE).
• Familiarity with GMP regulations and relevant pharmaceutical industry standards for biologics .

Benefits

• Attractive annual salary and comprehensive benefits package.
• Opportunity to work with cutting-edge biologics technology and processes.
• Continuous learning and professional development programs.
• Relocation assistance may be available for qualified candidates.
• A collaborative and innovative work environment in Pretoria .