Senior Process Development Engineer

Placements24; Bloemfontein; Hybrid; ZAR 1,200,000 - 1,700,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Performance-based bonuses

Career development opportunities

Job summary

Placements24 is seeking a Senior Process Development Engineer in Bloemfontein, Free State, to optimize and scale up complex biopharmaceutical processes. The role combines on-site laboratory work with remote strategic planning and data analysis, collaborating across R&D, manufacturing, and quality teams.

You will lead process development from design through tech transfer, ensuring GMP-compliant, robust production of life-saving medicines while mentoring junior engineers and staying current with

Qualifications

• Master’s or Ph.D. in Chemical Engineering, Biochemical Engineering, or related field.
• At least 6 years of process development experience in pharma/biotech.
• Experience designing, scaling, and optimizing biopharmaceutical manufacturing (cell culture, fermentation, purification).
• Strong understanding of PAT and QbD principles.
• Experience with process modeling/simulation software is desirable.
• Excellent problem-solving, analytical, and project management skills.
• Strong communication and cross-functional collaboration abilities.
• Familiarity with GMP and validation principles.

Responsibilities

• Design, develop, and optimize biopharmaceutical manufacturing processes (upstream and downstream).
• Lead technology transfer from lab to pilot plant and commercial scale.
• Troubleshoot deviations and implement corrective actions to improve robustness.
• Perform risk assessments and mitigation for process-related risks.
• Collaborate with R&D, manufacturing, and quality teams to progress projects.

Skills

Process development

Problem solving

Project management

Cross-functional teamwork

Communication skills

GMP knowledge

Hybrid work adaptability

Regulatory awareness

Education

MSc or PhD in Chemical/Biochemical Eng

Tools

Process modeling software

PAT tools

Job description

About the Role

Our client, a leading biopharmaceutical manufacturer, is seeking a highly skilled and innovative Senior Process Development Engineer to join their team in Bloemfontein, Free State. This role is essential for optimizing and scaling up complex manufacturing processes for novel pharmaceutical products. You will be instrumental in ensuring the efficient, robust, and compliant production of life-saving medicines. The position involves a hybrid work arrangement, allowing for both on-site laboratory and manufacturing floor involvement, as well as remote strategic planning and data analysis. You will collaborate with research, manufacturing, and quality assurance teams to bring new therapies from development to commercialization.

Key Responsibilities

• Design, develop, and optimize biopharmaceutical manufacturing processes, including upstream and downstream operations.
• Conduct process characterization studies to understand critical process parameters (CPPs) and critical quality attributes (CQAs).
• Develop and validate process models to predict and control process performance.
• Lead technology transfer activities for new processes from laboratory to pilot plant and commercial scale.
• Troubleshoot manufacturing deviations and implement effective corrective actions to improve process robustness.
• Perform risk assessments and implement mitigation strategies for process-related risks.
• Collaborate with R&D, manufacturing, and quality teams to ensure seamless project progression.
• Prepare technical reports, process documentation, and regulatory submission documents.
• Stay abreast of new technologies and methodologies in biopharmaceutical process development.
• Mentor junior engineers and provide technical guidance to the process development team.
• Ensure adherence to GMP, safety regulations, and company SOPs throughout all process development activities.

Requirements

• A Master’s or Ph.D. degree in Chemical Engineering, Biochemical Engineering, or a related field.
• A minimum of 6 years of relevant experience in process development within the pharmaceutical or biotechnology industry.
• Proven expertise in designing, scaling, and optimizing biopharmaceutical manufacturing processes (e.g., cell culture, fermentation, purification).
• Strong understanding of process analytical technology (PAT) and Quality by Design (QbD) principles.
• Experience with process modeling and simulation software is highly desirable.
• Excellent problem-solving, analytical, and project management skills.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
• Familiarity with GMP regulations and validation principles.
• Ability to work effectively in a hybrid setting, managing both on-site and remote tasks.
• Must be legally authorized to work in South Africa.

Benefits

Our client offers a competitive salary and benefits package, including comprehensive health insurance, retirement planning, and performance-based bonuses. The hybrid work environment provides flexibility and work-life balance. The company invests in employee development through continuous training, professional workshops, and opportunities for career progression. Join a forward-thinking organization at the forefront of pharmaceutical innovation.