Biopharma Process Engineer: Scale-Up & Process Development

Placements24

Stellenbosch

On-site

ZAR 900,000 - 1,500,000

Full time

4 days ago
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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

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

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