Lead Process Development Engineer - Pharmaceuticals

Placements24; Vereeniging; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Remote work from SA

Health insurance

Retirement planning

Training & development

Flexible schedule

Job summary

Placements24 is seeking a Lead Process Development Engineer for a fully remote role based in South Africa. You will lead a team of engineers and scientists, translating laboratory-scale discoveries into scalable manufacturing processes for new pharmaceutical products.

You will drive process design, optimization, and technology transfer from lab to pilot and commercial scales, ensuring GMP compliance and robust CPPs while collaborating with global R&D and manufacturing teams.

Qualifications

• Master's or PhD in Chemical Engineering with pharma process development focus.
• 9+ years hands-on experience in pharmaceutical process development and scale-up.
• Proven expertise in designing and optimizing complex chemical synthesis and purification processes for APIs.
• Strong GMP knowledge and regulatory awareness (FDA/EMA).
• Experience with process simulation software (Aspen Plus, SuperPro Designer) and statistical analysis tools.

Responsibilities

• Lead development and optimization of chemical processes for APIs and drug products.
• Design and scale-up processes from laboratory to pilot plant and commercial manufacturing scales.
• Conduct detailed process modeling, simulation, and risk assessments.
• Develop robust control strategies and CPPs for manufacturing processes.
• Oversee technology transfer activities to manufacturing sites, ensuring smooth implementation and validation.
• Mentor and guide junior process development engineers and scientists within the remote team.
• Collaborate closely with formulation scientists, analytical chemists, and regulatory affairs specialists.
• Troubleshoot and resolve technical challenges encountered during process development and scale-up.
• Author and review technical documentation, validation protocols, and regulatory submission documents.
• Stay current with advancements in pharmaceutical process technology, automation, and PAT.

Skills

Leadership

Strategic thinking

Communication

Remote team management

Education

Master's/PhD in Chemical Engineering

Tools

Aspen Plus

SuperPro Designer

PAT tools

Job description

About the Role

Our client, a highly respected pharmaceutical company at the forefront of drug development, is seeking an experienced Lead Process Development Engineer for a fully remote position. This role is critical for translating laboratory-scale discoveries into robust, scalable manufacturing processes for new pharmaceutical products. You will lead a team of engineers and scientists, driving innovation in process design, optimization, and technology transfer. This remote opportunity allows you to contribute significantly to life-saving medicines from anywhere in **South Africa**, collaborating closely with global R&D and manufacturing teams. We are looking for a visionary leader passionate about advancing **chemical engineering** in the pharmaceutical sector, ensuring the efficient and safe production of vital medications. The role demands exceptional technical expertise and leadership in a dynamic, fast-paced industry.

Key Responsibilities

• Lead the development and optimization of chemical processes for active pharmaceutical ingredients (APIs) and drug products.
• Design and scale-up processes from laboratory to pilot plant and commercial manufacturing scales.
• Conduct detailed process modeling, simulation, and risk assessments.
• Develop robust control strategies and critical process parameters (CPPs) for manufacturing processes.
• Oversee technology transfer activities to manufacturing sites, ensuring smooth implementation and validation.
• Mentor and guide junior process development engineers and scientists within the remote team.
• Collaborate closely with formulation scientists, analytical chemists, and regulatory affairs specialists.
• Troubleshoot and resolve technical challenges encountered during process development and scale-up.
• Author and review technical documentation, validation protocols, and regulatory submission documents.
• Stay current with advancements in pharmaceutical process technology, automation, and PAT (Process Analytical Technology).

Requirements

• Master's or Ph.D. in Chemical Engineering or a related field with a specialization in pharmaceutical process development.
• Minimum of 9 years of hands‑on experience in the pharmaceutical industry, focusing on process development and scale-up.
• Proven expertise in designing and optimizing complex chemical synthesis and purification processes for APIs.
• Strong understanding of GMP (Good Manufacturing Practices) and regulatory requirements (e.g., FDA, EMA).
• Experience with process simulation software (e.g., Aspen Plus, SuperPro Designer) and statistical analysis tools.
• Demonstrated leadership skills and experience managing technical projects and teams in a remote setting.
• Excellent problem‑solving, analytical, and critical thinking abilities.
• Outstanding written and verbal communication skills, with the ability to present complex data effectively.
• Familiarity with QbD (Quality by Design) principles and PAT implementation is highly desirable.
• Must be based in **South Africa** and comfortable working effectively in a fully remote capacity.

Benefits

This role offers a highly competitive salary and a comprehensive benefits package, including excellent health insurance and retirement planning options. As a fully remote position, it provides unparalleled flexibility. Our client is committed to professional development, offering extensive training programs, opportunities to attend virtual conferences, and support for further education. Employees benefit from a flexible work schedule and a collaborative, digitally enabled work environment. Join us in making a significant impact on global health through cutting‑edge **chemical engineering** and innovation, working remotely from **Vereeniging**, **Gauteng**, **South Africa**.