About the Role
Our client is seeking a skilled and innovative Pharmaceutical Process Engineer to join their esteemed manufacturing division in Rustenburg, North West. This role is crucial for optimizing and scaling up pharmaceutical manufacturing processes, ensuring efficiency, compliance, and product quality. You will be involved in the design, development, validation, and continuous improvement of manufacturing processes for a diverse range of pharmaceutical products. The ideal candidate will possess a strong engineering background, coupled with a deep understanding of pharmaceutical manufacturing principles and regulatory requirements. This is a prime opportunity to contribute to a company that is at the forefront of pharmaceutical innovation and production in Rustenburg, North West.
Key Responsibilities
- Design, develop, and optimize pharmaceutical manufacturing processes to enhance yield, reduce costs, and improve product quality.
- Lead process validation activities, including protocol development, execution, and reporting, in compliance with regulatory standards (e.g., GMP).
- Troubleshoot and resolve manufacturing process issues, identifying root causes and implementing effective solutions.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure seamless process integration and scale-up.
- Develop and maintain Standard Operating Procedures (SOPs) and batch records related to manufacturing processes.
- Evaluate and recommend new technologies and equipment to improve manufacturing efficiency and capabilities.
- Conduct process hazard analyses (PHAs) and implement safety measures to ensure a safe working environment.
- Generate process data and documentation for regulatory submissions and internal reviews.
- Mentor junior engineers and technicians, providing technical expertise and guidance.
- Stay updated with industry trends, best practices, and regulatory changes in pharmaceutical manufacturing.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
- A Master's degree is preferred.
- Minimum of 5 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- Strong understanding of GMP, FDA, and other relevant regulatory guidelines for pharmaceutical manufacturing.
- Proven experience in process design, scale-up, validation, and troubleshooting.
- Familiarity with various pharmaceutical manufacturing unit operations (e.g., granulation, tableting, sterile filling, lyophilization).
- Proficiency in process simulation software and data analysis tools.
- Excellent problem-solving, analytical, and project management skills.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
- Experience in the Rustenburg, North West area is beneficial.
- Ability to work effectively in both independent and team settings.
Benefits
- Our client offers a competitive salary, comprehensive benefits package including medical aid, retirement savings plan, and performance incentives.
- Opportunities for professional development, including advanced training and conference attendance, are readily available.
- The company promotes a collaborative work environment and offers a good work-life balance.
- This role is based in Rustenburg, North West, providing a chance to grow within a significant pharmaceutical manufacturing hub.