About the Role
Our client, a leading pharmaceutical manufacturer based in **Queenstown, Eastern Cape**, is seeking a highly skilled Process Engineer to join their Quality-focused manufacturing team. This is a critical on-site role responsible for the design, optimization, scale-up, and validation of processes used in the production of life-saving pharmaceutical products. You will play a vital part in ensuring that all processes meet stringent regulatory requirements (e.g., GMP) and achieve optimal efficiency, yield, and safety. The ideal candidate will possess a strong background in chemical engineering principles applied within a highly regulated pharmaceutical environment. Your expertise will be crucial in troubleshooting manufacturing issues, implementing process improvements, and supporting new product introductions. We are looking for an individual with meticulous attention to detail, excellent analytical capabilities, and a commitment to quality and compliance. This role offers a unique opportunity to contribute to the healthcare sector and advance your career within a company dedicated to innovation and patient well-being. The position requires full-time presence at the facility to collaborate closely with production, quality control, and validation teams.
Key Responsibilities
- Design, develop, and optimize chemical processes for pharmaceutical manufacturing.
- Ensure all processes comply with Good Manufacturing Practices (GMP) and other regulatory standards.
- Develop process validation protocols and execute validation studies.
- Troubleshoot process deviations and implement corrective and preventive actions (CAPAs).
- Conduct Process Hazard Analyses (PHAs) and implement necessary safety controls.
- Scale-up processes from laboratory/pilot scale to commercial manufacturing.
- Prepare detailed technical documentation, including batch records, SOPs, and validation reports.
- Collaborate with R&D, Quality Assurance, and Production teams to ensure successful technology transfer.
- Monitor process performance and identify opportunities for efficiency and yield improvements.
- Support equipment qualification and process automation initiatives.
Requirements
- Bachelor's or Master's degree in Chemical Engineering or a related field.
- Minimum of 5 years of experience in process engineering within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GMP regulations and pharmaceutical manufacturing processes.
- Proven experience in process validation, scale-up, and technology transfer.
- Strong understanding of unit operations relevant to pharmaceutical production (e.g., filtration, drying, crystallization).
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in process simulation software is advantageous.
- Strong written and verbal communication skills, with the ability to document complex technical information clearly.
- Ability to work collaboratively in a cross-functional team environment.
- Experience with Quality by Design (QbD) principles is a plus.
Benefits
- Our client offers a competitive salary, comprehensive health insurance, retirement savings plan, and performance-based bonuses.
- You will be part of a mission-driven organization focused on improving global health outcomes.
- Opportunities for professional development, including specialized pharmaceutical engineering training, are readily available.
- The company fosters a culture of collaboration, innovation, and continuous improvement.
- This role provides a direct impact on the availability of essential medicines and offers a stable career path within the pharmaceutical sector.
- We offer a supportive work environment and invest in our employees' growth and well-being.
- The site is equipped with advanced manufacturing technology, providing exposure to cutting-edge pharmaceutical production.