Lead Pharma Process Development Engineer – Hybrid (Stellenbosch)

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

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.