Our client is seeking an experienced Senior Process Engineer with a specialization in the pharmaceutical industry for their facility in Kimberley . This role is critical for the development, scale-up, and optimization of manufacturing processes for pharmaceutical products, ensuring adherence to strict GMP (Positive Manufacturing Practices) regulations. You will work closely with R&D;, quality assurance, and production teams to bring cutting-edge therapies from the lab to full-scale manufacturing. The ideal candidate possesses a strong understanding of bioprocessing or chemical synthesis relevant to pharmaceuticals and a commitment to quality and compliance.
Key Responsibilities
- Develop and optimize chemical or biological processes for pharmaceutical manufacturing.
- Lead scale-up activities from laboratory to pilot plant and commercial production.
- Author and review process documentation, including batch records and validation protocols.
- Troubleshoot manufacturing issues and implement corrective actions to maintain product quality and yield.
- Ensure all processes comply with GMP, FDA, and other relevant regulatory guidelines.
- Collaborate with cross-functional teams to support process validation and technology transfer.
Requirements
- Bachelor's or Master's degree in Chemical Engineering or a related life sciences discipline.
- 5+ years of experience in process engineering within the pharmaceutical or biotechnology industry.
- Thorough understanding of GMP, process validation, and regulatory requirements.
- Experience with unit operations common in pharmaceutical manufacturing (e.g., fermentation, purification, crystallization, drying).
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and teamwork abilities for effective collaboration in Kimberley .
Benefits
- Market-competitive salary and annual bonus.
- Comprehensive health and retirement benefits package.
- Opportunities for professional growth and specialized training in pharmaceutical manufacturing.
- Exposure to cutting-edge pharmaceutical development projects.
- A culture that prioritizes quality, safety, and employee development.