Senior Biologics Process Engineer (Remote)

Placements24; Bloemfontein; Híbrido; ZAR 1.200.000 - 1.900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Remote work flexibility

Retirement savings plan

Professional development

Global impact

Descripción de la vacante

Placements24 seeks a Senior Biologics Process Engineer to design, develop, optimize, and scale biologics manufacturing processes for drug substances. You will work remotely with a global team, applying cell culture, purification, and downstream processing expertise to drive improvements and enable robust production.

The role emphasizes process validation, technology transfer, DoE, and data-driven problem solving in a virtual setting, with collaboration across R&D, manufacturing, and QA to ensure

Formación

• Master's or PhD in Chemical/Biochemical Engineering, Biotechnology, or related field.
• 7+ years in process development/engineering for biologics manufacturing.
• Experience with cell culture, purification, scale-up and tech transfer.
• Familiarity with DoE, statistical analysis and process modeling software.
• Proven ability to work independently in a remote, global team.

Responsabilidades

• Lead development, optimization, and scale-up of upstream and downstream biologics processes.
• Design and run experiments to improve yield, process performance and quality.
• Develop and implement process validation strategies per global regulations.
• Use modeling/simulation tools to predict behavior and optimize operating conditions.
• Analyze data trends and implement data-driven improvements.
• Support tech transfer, troubleshoot production issues, and ensure GMP compliance.
• Prepare technical and regulatory documents and mentor junior staff.

Conocimientos

Statistical analysis

Design of Experiments

Data-driven decision making

Remote work leadership

Strong communication

Educación

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

Herramientas

Process modeling software

Single-use technologies

Descripción del empleo

About the Role Our client, a leading biopharmaceutical company at the forefront of therapeutic innovation, is seeking a highly skilled Senior Biologics Process Engineer to join their globally distributed, fully remote team. This role is essential for the design, development, optimization, and scale-up of manufacturing processes for biologic drug substances. You will apply your extensive knowledge of cell culture, purification, and downstream processing to ensure the efficient and robust production of life-changing biologics. As a remote engineer, you will leverage advanced modeling, simulation, and digital tools to drive process improvements and troubleshoot complex challenges. This position offers a unique opportunity to shape the future of biomanufacturing and contribute significantly to the advancement of novel therapies. The ideal candidate possesses a deep technical understanding of bioprocessing principles, extensive experience with process validation, and a proactive approach to problem-solving in a virtual setting. You will collaborate with R&D, manufacturing operations, and quality assurance teams to ensure seamless process implementation and regulatory compliance.

Key Responsibilities

• Lead the development, optimization, and scale-up of upstream (cell culture) and downstream (purification) processes for biologic drug substances (e.g., monoclonal antibodies, recombinant proteins).
• Design and execute experiments to improve process performance, yield, and product quality, identifying Critical Process Parameters (CPPs).
• Develop and execute process validation strategies and protocols in compliance with global regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Utilize process modeling and simulation tools to predict process behavior, optimize operating conditions, and troubleshoot issues.
• Analyze process data, identify trends, and implement data-driven solutions for continuous improvement.
• Collaborate with manufacturing sites to support process transfer, troubleshoot production issues, and ensure operational efficiency.
• Prepare comprehensive technical reports, validation documents, and regulatory submission support documents.
• Evaluate and recommend new technologies and equipment for biopharmaceutical manufacturing.
• Provide technical guidance and mentorship to junior engineers and scientists.
• Ensure all activities comply with Good Manufacturing Practices (GMP), safety regulations, and environmental standards.

Requirements

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 7 years of experience in process development and engineering for biologics manufacturing.
• In-depth knowledge of mammalian cell culture, microbial fermentation, and/or protein purification technologies.
• Proven experience in process scale-up, technology transfer, and process validation.
• Familiarity with statistical analysis, Design of Experiments (DoE), and process modeling software.
• Excellent problem-solving skills and a rigorous, data-driven approach.
• Strong written and verbal communication skills, with the ability to present complex technical information clearly.
• Demonstrated ability to work independently and lead projects effectively in a remote environment.
• Experience with single-use technologies and continuous manufacturing is a plus.
• Understanding of regulatory requirements for biologics is essential.

Benefits

• Competitive annual salary of R.
• Comprehensive health, dental, and vision insurance.
• Flexible remote work schedule with home office support.
• Retirement savings plan with generous company matching.
• Significant opportunities for professional development, training, and attending industry conferences.
• Exposure to cutting-edge biopharmaceutical technologies and drug development programs.
• Chance to make a substantial impact on global health by advancing the production of critical medicines.
• Collaborative and innovative virtual team environment.