About the Role
Our client, a reputable pharmaceutical manufacturing company, is seeking a skilled Pharmaceutical Process Engineer to enhance its operations in Benoni, Gauteng . This role is integral to optimizing and scaling up pharmaceutical production processes, ensuring efficiency, safety, and compliance with stringent industry standards. The Process Engineer will be involved in the design, development, implementation, and troubleshooting of manufacturing processes for various pharmaceutical products. This position offers a stimulating environment for an engineer passionate about process improvement and innovation within the pharmaceutical sector. The ideal candidate will possess a strong understanding of chemical engineering principles, GMP guidelines, and process validation techniques. You will collaborate closely with production, quality assurance, and R&D teams to drive continuous improvement and maintain operational excellence. Your contributions will be key to ensuring the robust and efficient manufacture of high-quality medicines.
Key Responsibilities
- Design, develop, and optimize pharmaceutical manufacturing processes to improve yield, efficiency, and cost-effectiveness.
- Lead process validation activities, including developing validation protocols, executing validation batches, and preparing validation reports.
- Troubleshoot process-related issues, identify root causes, and implement effective solutions to minimize disruptions.
- Ensure all processes comply with Good Manufacturing Practices (GMP), safety regulations, and environmental standards.
- Collaborate with the R&D department on technology transfer of new products from lab scale to commercial manufacturing.
- Develop and maintain process documentation, including Standard Operating Procedures (SOPs), batch records, and engineering drawings.
- Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities.
- Participate in cross-functional teams for process hazard analyses (PHAs) and risk assessments.
- Monitor process performance, collect and analyze data, and report on key performance indicators (KPIs).
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field. A Master's degree is an advantage.
- Minimum of 4-6 years of experience in process engineering within the pharmaceutical or biotech industry.
- Strong understanding of pharmaceutical manufacturing processes, unit operations, and equipment.
- In-depth knowledge of GMP, FDA, and other relevant regulatory requirements.
- Experience with process validation, qualification, and scale-up activities.
- Proficiency in process simulation software (e.g., Aspen Plus) and CAD tools is desirable.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to document technical information clearly.
- Ability to work effectively both independently and as part of a collaborative team.
Benefits
- Competitive salary and potential for performance-based bonuses.
- Comprehensive medical aid, retirement fund, and life insurance benefits.
- Opportunities for professional development, including training courses and industry certifications.
- Paid annual leave and sick leave.
- Exposure to diverse pharmaceutical projects and cutting-edge technologies.
- A supportive work environment that encourages innovation and collaboration.