Lead Pharmaceutical Process Development Engineer

Placements24; Stellenbosch; Hybrid; ZAR 1,200,000 - 2,100,000; Full time

Benefits offered by this job

Executive salary

Health insurance

Retirement plan

Paid vacation

Professional development

Hybrid work model

Job summary

Placements24 in Stellenbosch, Western Cape, seeks an experienced Lead Pharmaceutical Process Development Engineer to lead development, scale-up, and optimization of manufacturing processes from pilot to commercial production.

The role emphasizes robust, compliant processes, leadership of cross-functional teams, and close collaboration with R&D, manufacturing, QA, and regulatory affairs to ensure cGMP compliance. Hybrid work setup in Stellenbosch region.

Qualifications

• Master's or Ph.D. in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• 8+ years in pharmaceutical process development and scale-up.
• Strong knowledge of QbD, PAT, and regulatory requirements (FDA, EMA, SAHPRA).

Responsibilities

• Lead process development activities for pharmaceutical manufacturing, including process design, optimization, and scale-up.
• Develop and execute experimental plans to investigate CPPs and establish design spaces.
• Utilize Process Analytical Technology (PAT) and Quality by Design (QbD) principles.
• Prepare detailed process development reports, transfer documents, and validation protocols.
• Collaborate with R&D, manufacturing, quality assurance, and regulatory affairs teams.
• Troubleshoot and resolve technical issues related to manufacturing processes.
• Ensure all process development activities comply with cGMP and regulatory requirements.
• Evaluate and recommend new technologies and equipment for process improvements.
• Mentor junior engineers and technical staff.
• Manage multiple process development projects concurrently in Stellenbosch, Western Cape.

Skills

Leadership

Project management

Analytical skills

Cross-functional collaboration

Communication

Education

Master's or Ph.D. in Chemical Engineering or Pharmaceutical Engineering

Tools

Process modeling software

Job description

About the Role Our client, a global leader in pharmaceutical manufacturing, is seeking an experienced Lead Pharmaceutical Process Development Engineer for their facility in **Stellenbosch, Western Cape**. This senior role is responsible for leading the development, scale-up, and optimization of manufacturing processes for new and existing pharmaceutical products. You will play a key role in ensuring robust, efficient, and compliant manufacturing processes from pilot scale to commercial production. The ideal candidate will have a strong engineering background, extensive experience in pharmaceutical process development, and excellent leadership skills. This position offers the opportunity to shape the future of pharmaceutical manufacturing in the vibrant **Stellenbosch, Western Cape** region.

Key Responsibilities

• Lead process development activities for pharmaceutical manufacturing, including process design, optimization, and scale-up.
• Develop and execute experimental plans to investigate critical process parameters (CPPs) and establish design spaces.
• Utilize Process Analytical Technology (PAT) and Quality by Design (QbD) principles.
• Prepare detailed process development reports, transfer documents, and validation protocols.
• Collaborate with R&D, manufacturing, quality assurance, and regulatory affairs teams.
• Troubleshoot and resolve technical issues related to manufacturing processes.
• Ensure all process development activities comply with cGMP and regulatory requirements.
• Evaluate and recommend new technologies and equipment for process improvements.
• Mentor junior engineers and technical staff.
• Manage multiple process development projects concurrently in **Stellenbosch, Western Cape**.

Requirements

• Master's or Ph.D. degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• Minimum of 8 years of experience in pharmaceutical process development and scale-up.
• Proven experience with various pharmaceutical manufacturing technologies (e.g., solid dosage, sterile processing).
• Strong understanding of QbD, PAT, and regulatory requirements (FDA, EMA, SAHPRA).
• Excellent analytical, problem-solving, and project management skills.
• Demonstrated leadership capabilities and experience managing technical teams.
• Proficiency in process modeling and simulation software is a plus.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional, fast-paced environment.
• Must be legally authorized to work in **South Africa**.

Benefits

• Our client offers a competitive executive salary, substantial performance bonuses, comprehensive health insurance, and a generous retirement plan.
• Employees receive ample paid vacation time and significant opportunities for professional development and advanced training.
• This hybrid role provides flexibility, allowing you to contribute effectively from both the office in **Stellenbosch, Western Cape**, and remotely.

Join a dynamic team and make a significant impact on the pharmaceutical industry.