About the Role Our client, a leading pharmaceutical manufacturer, is seeking a skilled Process Development Engineer to join their dynamic team in **Queenstown, Eastern Cape**. This role is critical in developing, optimizing, and scaling up chemical processes for the production of pharmaceutical intermediates. You will be instrumental in ensuring processes are safe, efficient, reproducible, and compliant with stringent pharmaceutical industry standards (e.g., cGMP). The ideal candidate will possess a strong background in organic chemistry and chemical engineering, with practical experience in process development, scale-up, and validation. This position offers a challenging and rewarding career path within a vital sector of the **Eastern Cape** economy.
Key Responsibilities
- Develop and optimize chemical synthesis routes for pharmaceutical intermediates, focusing on yield, purity, and cost-effectiveness.
- Conduct laboratory experiments and pilot plant trials to evaluate process parameters and scalability.
- Perform process hazard analyses (PHAs) and implement safety measures appropriate for pharmaceutical manufacturing.
- Develop detailed process descriptions, P&IDs, and Standard Operating Procedures (SOPs).
- Validate new and modified manufacturing processes to ensure they meet cGMP requirements.
- Troubleshoot process issues encountered during development, scale-up, and routine manufacturing.
- Collaborate with R&D, quality assurance, regulatory affairs, and manufacturing teams.
- Analyze process data, generate technical reports, and present findings to project teams and management.
- Ensure all activities comply with cGMP, environmental, and safety regulations.
Requirements
- Master's degree or Ph.D. in Chemical Engineering or Organic Chemistry.
- Minimum of 5 years of experience in process development or chemical engineering within the pharmaceutical or fine chemical industry.
- Strong understanding of organic synthesis, reaction kinetics, and chemical engineering principles.
- Proven experience in process scale-up, from laboratory to pilot and commercial scale.
- Familiarity with cGMP regulations and validation principles is essential.
- Experience with process safety assessments and hazard analysis techniques.
- Proficiency in data analysis and statistical software (e.g., JMP, Minitab) is highly desirable.
- Excellent problem-solving, analytical, and communication skills.
- Ability to work effectively in a multidisciplinary team environment.
Benefits
- Competitive salary and performance bonus program.
- Comprehensive medical, dental, and vision insurance.
- Retirement savings plan.
- Generous paid time off and holiday schedule.
- Opportunities for professional development and advanced training.
- Exposure to cutting-edge pharmaceutical manufacturing.
- Relocation assistance may be considered for qualified candidates in **Queenstown**.