Process Development Engineer - Biologics
Job in
Pretoria, 0002, South Africa
Listed on 2026-09-21
Listing for:
Placements24
Full Time
position Listed on 2026-09-21
Job specializations:
-
Engineering
Process Engineer, Quality Engineering, Manufacturing Engineer, Validation Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing Engineer, Validation Engineer
Job Description & How to Apply Below
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.
- 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 .
- 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 .
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