Biopharmaceutical Process Engineer

Placements24; Mtubatuba Local Municipality; Hybrid; ZAR 900,000 - 1,600,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement savings plan

Career growth and training

Access to cutting-edge technology

Collaborative work environment

Job summary

Placements24 seeks a Biopharmaceutical Process Engineer to design, optimize, and scale biopharmaceutical manufacturing processes at Richards Bay. The role demands expertise in upstream and downstream bioprocessing, process validation, and regulatory compliance within GMP environments.

The ideal candidate will have 5+ years in biopharmaceutical development, strong analytical and communication skills, and experience with technology transfer and regulatory submissions.

Qualifications

• Minimum 5 years of experience in biopharmaceutical process development and manufacturing.

Responsibilities

• Develop, optimize, and scale-up biopharmaceutical manufacturing processes (cell culture, fermentation, purification).
• Design and implement process improvements to enhance yield, efficiency, and cost-effectiveness.
• Prepare and execute process validation protocols and reports for regulatory submissions.
• Troubleshoot process deviations and implement corrective actions to maintain product quality.
• Collaborate with R&D, manufacturing operations, and quality assurance to ensure GMP compliance.

Skills

Biopharmaceutical process development

Process validation

Technology transfer

GMP compliance

Regulatory compliance

Analytical problem-solving

Communication skills

Education

Master's degree in Chemical Engineering or Biochemical Engineering

Ph.D. in Chemical Engineering or Biochemical Engineering

Tools

Process modeling software

Simulation software

Job description

About the Role

Our client is seeking a skilled Biopharmaceutical Process Engineer to join their dynamic manufacturing team in Richards Bay. This role is instrumental in designing, optimizing, and scaling up biopharmaceutical manufacturing processes to ensure efficient and high-quality production of therapeutic biologics. You will work with state-of-the-art equipment and technologies, contributing to the development and commercialization of innovative treatments. This position requires a strong understanding of upstream and downstream bioprocessing, process validation, and regulatory compliance within a GMP environment.

Key Responsibilities

• Develop, optimize, and scale-up biopharmaceutical manufacturing processes (e.g., cell culture, fermentation, purification).
• Design and implement process improvements to enhance yield, efficiency, and cost-effectiveness.
• Prepare and execute process validation protocols and reports for regulatory submissions.
• Troubleshoot process deviations and implement corrective actions to maintain product quality and consistency.
• Collaborate with cross-functional teams, including R&D, manufacturing operations, and quality assurance.
• Ensure all process activities comply with Good Manufacturing Practices (GMP) and relevant regulatory requirements.
• Provide technical support for manufacturing operations and technology transfer activities.

Requirements

• Master's degree or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related field.
• Minimum of 5 years of experience in biopharmaceutical process development and manufacturing.
• Strong knowledge of upstream and downstream bioprocessing technologies and equipment.
• Experience with process validation, technology transfer, and GMP compliance.
• Proficiency in process modeling and simulation software is a plus.
• Excellent analytical, problem-solving, and communication skills.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan.
• Opportunities for professional growth and advanced training.
• Access to cutting-edge biopharmaceutical manufacturing technology.
• A collaborative and innovative work environment.