Biopharmaceutical Process Engineer

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

Benefits offered by this job

Performance-based bonuses

Medical aid

Life insurance

Retirement fund

Paid time off

Advanced training programs

Job summary

Placements24, in collaboration with a leading biopharmaceutical company in Stellenbosch, Western Cape, seeks a Biopharmaceutical Process Engineer. You will design, develop, optimize, and scale bioprocesses for biologics, covering upstream cell culture and downstream purification, while ensuring regulatory compliance and robust manufacturing performance.

This on-site role requires at least 5 years in process development or manufacturing within biopharma, hands-on experience with bioprocess unit

Qualifications

• Bachelor's or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology or related field.
• Minimum 5 years in process development, scale-up or manufacturing in biopharma.
• Hands-on with bioprocess unit operations (bioreactors, centrifuges, filtration, chromatography).
• Strong GMP/regulatory understanding and validation principles.
• Experience with process modeling and simulation software is a plus.
• Excellent analytical and problem-solving skills.
• Strong project management and cross-functional collaboration.
• Experience with SPC and DoE is advantageous.

Responsibilities

• Design, develop, and optimize upstream and/or downstream bioprocesses for biologics.
• Conduct development studies from lab to pilot scale and scale-up activities.
• Troubleshoot process issues and implement solutions to ensure quality and yield.
• Develop and implement process validation strategies per regulatory guidelines.
• Prepare and review process descriptions, validation protocols, and regulatory documents.
• Collaborate with manufacturing, QA, and analytical teams for tech transfer.
• Monitor process performance and drive continuous improvement.
• Ensure GMP, safety, and environmental compliance.
• Evaluate and adopt new technologies and equipment.

Skills

GMP knowledge

Process optimization

Cross-functional collaboration

Problem solving

Regulatory understanding

Education

Bachelor's/Master's in Chemical/Biochemical Engineering or Biotechnology

Tools

Process modeling software

SPC/DoE tooling

Job description

About the Role

Our client, a leading biopharmaceutical company at the forefront of developing innovative biologics, is seeking a highly skilled and experienced Biopharmaceutical Process Engineer. This critical role is based at their advanced manufacturing facility in Stellenbosch, Western Cape. You will be responsible for the design, development, optimization, and scale-up of biopharmaceutical manufacturing processes, ensuring efficiency, robustness, and regulatory compliance. The ideal candidate possesses a strong background in biochemical engineering, process development, and hands‑on experience with bioprocess equipment. This is an exceptional opportunity to contribute to the production of life‑saving therapies within a dynamic and collaborative research and manufacturing environment in the scenic Stellenbosch, Western Cape. This is a full‑time, on‑site role, essential for the hands‑on nature of process engineering and facility oversight.

Key Responsibilities

• Design, develop, and optimize upstream (cell culture, microbial fermentation) and/or downstream (purification, chromatography) bioprocesses for the manufacture of biologics.
• Conduct process development studies, including lab‑scale experiments, pilot‑scale trials, and scale‑up activities.
• Troubleshoot process issues, identify root causes, and implement effective solutions to ensure product quality and yield.
• Develop and implement process validation strategies in accordance with regulatory guidelines (e.g., FDA, EMA, SAHPRA).
• Author and review process descriptions, validation protocols, reports, and regulatory submission documents.
• Collaborate with manufacturing, quality assurance, and analytical teams to ensure seamless technology transfer and process implementation.
• Monitor process performance using relevant metrics and implement continuous improvement initiatives.
• Ensure all process activities comply with GMP, safety, and environmental regulations.
• Evaluate and implement new technologies and equipment to enhance biomanufacturing capabilities.

Requirements

• A Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related scientific/engineering discipline.
• A minimum of 5 years of experience in process development, scale‑up, or manufacturing within the biopharmaceutical industry.
• Hands‑on experience with various bioprocess unit operations (e.g., bioreactors, centrifuges, filtration, chromatography systems).
• Strong understanding of GMP, regulatory requirements, and validation principles for biopharmaceuticals.
• Proficiency in process modeling and simulation software is a plus.
• Excellent analytical, problem‑solving, and critical thinking skills.
• Strong project management and organizational abilities.
• Effective communication and interpersonal skills, with the ability to work collaboratively in cross‑functional teams.
• Experience with statistical process control (SPC) and Design of Experiments (DoE) is advantageous.

Benefits

• Our client offers a competitive salary, performance‑based bonuses, and an extensive benefits package, including excellent medical aid coverage, life insurance, and a robust retirement fund.
• This role offers significant opportunities for career advancement and professional development within a leading biopharmaceutical company.
• The position is based in the beautiful Stellenbosch, Western Cape, providing a high quality of work and life.
• Employees enjoy ample paid time off and access to advanced training programs.
• You will be part of a forward‑thinking team driving innovation in biologics manufacturing.