About the Role
Our client, a pioneering global pharmaceutical company, is seeking an innovative and experienced Process Development Engineer to join their distributed engineering team. This is a fully **remote** position, allowing you to contribute to the optimization and scaling of pharmaceutical manufacturing processes from any location within **South Africa**. You will be responsible for designing, developing, and implementing efficient and robust manufacturing processes for novel drug products, ensuring compliance with stringent regulatory standards. This role is critical in bridging the gap between laboratory-scale innovation and full-scale commercial production. If you are a results-oriented engineer with a deep understanding of pharmaceutical manufacturing principles and a desire to work in a flexible, remote environment, this opportunity is for you.
Key Responsibilities
- Design, develop, and optimize pharmaceutical manufacturing processes, focusing on efficiency, scalability, and cost-effectiveness.
- Conduct process validation studies and develop robust control strategies.
- Troubleshoot manufacturing issues and implement corrective and preventive actions (CAPAs).
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure seamless process transfer and scale-up.
- Develop process documentation, including batch records, SOPs, and validation protocols.
- Utilize process modeling and simulation tools to predict and optimize process performance.
- Stay current with emerging technologies and best practices in pharmaceutical process engineering.
- Ensure all activities comply with cGMP, FDA, EMA, and other relevant regulatory guidelines.
- Evaluate and select appropriate manufacturing equipment and technologies.
- Contribute to the development of intellectual property through process innovation.
Requirements
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical process development and manufacturing.
- Strong understanding of unit operations in pharmaceutical manufacturing (e.g., granulation, drying, milling, tablet compression, sterile filling).
- Proficiency in process validation principles and statistical process control (SPC).
- Experience with Good Manufacturing Practices (GMP) and regulatory requirements.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong project management and communication skills, with the ability to collaborate effectively in a remote setting.
- Experience with process simulation software (e.g., Aspen Plus, gPROMS) is a significant advantage.
- Ability to work independently and manage multiple priorities in a remote environment.
- Knowledge of QbD (Quality by Design) principles is highly desirable.
Benefits
- Our client offers a highly competitive salary, commensurate with experience, and a comprehensive benefits package including health insurance, retirement plan contributions, and generous paid time off.
- This position is fully **remote**, offering unparalleled flexibility and autonomy.
- Professional development opportunities, including specialized training and exposure to cutting-edge technologies, are provided.
- Our client is committed to fostering a culture of innovation, collaboration, and continuous improvement.
- Working from anywhere within **South Africa**, you will contribute to global health initiatives while maintaining a healthy work-life balance.
- We encourage applications from experienced engineers looking for a challenging and rewarding career.