Lead Process Engineer - Pharmaceutical API Production
Stellenbosch, 7600, South Africa
Listed on 2026-09-19
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Engineering
Process Engineer, Pharma Engineer, Validation Engineer, Quality Engineering -
Pharmaceutical
Pharma Engineer, Validation Engineer, Quality Engineering
About the Role
Our client is seeking an accomplished Lead Process Engineer to oversee and advance their pharmaceutical API production processes. This is a fully remote position, allowing you to leverage your expertise from anywhere within South Africa , contributing to a critical sector that impacts global health. You will lead the design, optimization, and validation of manufacturing processes, ensuring compliance with stringent Good Manufacturing Practices (GMP).
This role demands exceptional technical leadership, a deep understanding of pharmaceutical chemistry, and a commitment to innovation and quality in a virtual collaboration environment. You will guide a team of engineers and work closely with regulatory affairs and quality assurance departments.
- Lead the design, development, and optimization of processes for Active Pharmaceutical Ingredient (API) manufacturing.
- Ensure all processes comply with cGMP, FDA, and other relevant regulatory requirements.
- Oversee process validation activities and ensure data integrity for regulatory submissions.
- Troubleshoot complex process issues and implement robust, sustainable solutions.
- Mentor and guide a team of process engineers, fostering a culture of continuous improvement and technical excellence.
- Collaborate effectively with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, in a remote setting.
- Bachelor's or Master's degree in Chemical Engineering or a related field.
- Minimum of 10 years of experience in process engineering within the pharmaceutical industry, with significant API experience.
- In-depth knowledge of cGMP, process validation, and regulatory guidelines.
- Proven experience in leading engineering teams and managing complex projects.
- Exceptional analytical, problem-solving, and communication skills for remote collaboration.
- Experience with process modeling and simulation is advantageous.
- Highly attractive annual salary package.
- Full remote work flexibility across South Africa .
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and professional development allowance.
- Opportunity to lead critical projects in the pharmaceutical sector.
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