Senior Process Engineer - Pharmaceutical

Placements24; Mbombela (Nelspruit); On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Salary bonus potential

Medical benefits

Retirement plan

Job summary

Placements24 in Nelspruit seeks a Senior Process Engineer to lead pharmaceutical manufacturing process development, optimization, and scale-up in a GMP-regulated facility. You will drive cross-functional projects, validate equipment, and ensure product quality and regulatory compliance.

The role emphasizes process validation, technology transfer, and continuous improvement, with opportunities for international training and professional development within a dynamic pharmaceutical environment.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering or related field.
• Minimum 8 years of process engineering experience in pharmaceutical/biopharmaceutical industry.
• Solid GMP knowledge and regulatory awareness (FDA/EMA).
• Experience with process validation, tech transfer, and scale-up activities.
• Proficiency with process simulation and data analysis tools.
• Strong project management, problem-solving, and communication skills.

Responsibilities

• Design, develop, and scale up pharmaceutical manufacturing processes (upstream and downstream).
• Optimize processes to improve yield, reduce costs, and maintain GMP compliance.
• Conduct IQ/OQ/PQ validation studies for equipment and systems.
• Troubleshoot deviations and CAPA implementation.
• Develop and review batch records, SOPs, and regulatory documentation.
• Collaborate with QA, R&D, and Production to ensure seamless integration and continuous improvement.

Skills

GMP compliance

Regulatory knowledge

Project management

Problem solving

Communication

Education

Bachelor's or Master's in Chemical Engineering

Tools

Process simulation

Data analysis tools

Job description

About the Role

Our client is seeking a highly experienced Senior Process Engineer with a specialization in the Pharmaceutical industry to join their state-of-the-art facility in Nelspruit . This role is central to the development, optimization, and scale-up of pharmaceutical manufacturing processes, ensuring compliance with rigorous GMP standards. You will lead critical projects, troubleshoot complex issues, and collaborate with cross-functional teams to deliver high-quality pharmaceutical products efficiently and safely. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing principles and a proven ability to drive process improvements in a regulated environment.

Key Responsibilities

• Design, develop, and scale up pharmaceutical manufacturing processes, including upstream and downstream operations.
• Optimize existing processes to improve yield, reduce costs, and enhance product quality while maintaining GMP compliance.
• Conduct validation studies (IQ, OQ, PQ) for new and modified process equipment and systems.
• Troubleshoot process deviations and equipment failures, implementing effective corrective and preventive actions (CAPAs).
• Develop and review batch records, SOPs, and technical documentation in accordance with regulatory requirements.
• Collaborate with Quality Assurance, R&D, and Production teams to ensure seamless process integration and continuous improvement.

Requirements

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• Minimum of 8 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, EMA).
• Experience with process validation, technology transfer, and scale-up activities.
• Proficiency in process simulation and data analysis tools.
• Strong project management, problem-solving, and communication skills.

Benefits

• Highly competitive salary and bonus potential.
• Comprehensive medical, dental, and vision insurance.
• Generous retirement plan with company matching.
• Opportunities for international training and professional development.
• A dynamic and innovative work environment within the pharmaceutical sector.