About the Role
Our client, a leading pharmaceutical manufacturer committed to innovation and quality, is seeking an experienced Senior Pharmaceutical Process Engineer for their facility located in Queenstown, Eastern Cape. This role is integral to optimizing and ensuring the efficiency, safety, and scalability of our pharmaceutical manufacturing processes. The ideal candidate will possess a strong engineering background, extensive experience in the pharmaceutical industry, and a proven ability to implement process improvements and troubleshoot complex manufacturing challenges. You will play a key role in driving operational excellence, supporting new product introductions, and ensuring compliance with stringent regulatory standards. The Queenstown location offers a unique opportunity to contribute to a vital industry within a developing region.
Key Responsibilities
- Design, develop, optimize, and scale up pharmaceutical manufacturing processes to meet production demands and quality standards.
- Lead process validation activities, including protocol development, execution, and reporting.
- Troubleshoot and resolve process-related issues, identifying root causes and implementing effective corrective actions.
- Implement process improvements to enhance efficiency, reduce costs, and minimize waste.
- Ensure all processes comply with Good Manufacturing Practices (GMP), safety regulations, and environmental standards.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to support new product introductions and process changes.
- Develop and maintain process documentation, including SOPs, batch records, and engineering drawings.
- Evaluate and recommend new technologies and equipment to improve manufacturing capabilities.
- Conduct process hazard analyses (PHAs) and implement necessary safety measures.
- Mentor junior engineers and provide technical guidance on process engineering principles.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field. A Master's degree is a plus.
- Minimum of 7 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of pharmaceutical unit operations (e.g., granulation, drying, blending, tablet compression, sterile filling).
- Proven experience in process validation, IQ/OQ/PQ, and scale-up activities.
- Strong understanding of GMP, FDA, and EMA regulatory requirements.
- Proficiency in process simulation software and data analysis tools.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong project management and communication skills.
- Ability to work effectively in a cross-functional team environment.
- Experience with Lean Manufacturing or Six Sigma methodologies is highly desirable.
Benefits
- Our client offers a competitive salary package, performance-based incentives, and potential for overtime pay.
- Comprehensive medical aid, retirement fund contributions, and life insurance are provided.
- Employees receive generous annual leave and paid sick leave.
- Opportunities for professional development, including advanced engineering courses and certifications, are readily available.
- A challenging yet rewarding work environment focused on innovation and quality is offered.
- The Queenstown location provides a stable employment opportunity within a critical sector.