Senior Pharma Process Development Engineer

Placements24; Centurion; Presencial; ZAR 1 100 000 - 1 600 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Retirement savings plan

Performance bonuses

Resumo da oferta

Placements24 seeks a Senior Process Development Engineer for a leading pharmaceutical manufacturer in Centurion, Gauteng. The role focuses on optimizing and scaling up manufacturing processes to ensure efficiency, quality, and cost-effectiveness.

You will design DoE studies, develop validation strategies, troubleshoot deviations, and drive technology transfer. Collaboration with R&D, QA, and Manufacturing is essential, with mentorship for junior engineers.

Qualificações

• Bachelor's or Master's degree in Chemical or Mechanical Engineering.
• 5–7 years within pharma process development/manufacturing.
• Experience in scale-up, validation.
• GMP/regulatory knowledge (FDA/EMA).
• Proficiency in JMP or Minitab for modeling.

Responsabilidades

• Lead the development, optimization, and scale-up of pharmaceutical manufacturing processes (e.g., API synthesis, formulation, filling/finishing).
• Design experiments (DoE) to identify CPPs and establish robust operating ranges.
• Develop process validation strategies and execute validation protocols to demonstrate process reproducibility and reliability.
• Troubleshoot manufacturing process deviations and implement CAPAs.
• Collaborate with R&D, QA, and Manufacturing to ensure technology transfer and process implementation.
• Write and review process development reports, validation documents, and technical transfer packages.
• Ensure all process development and manufacturing activities comply with GMP and relevant regulatory requirements.
• Stay current with advancements in pharmaceutical manufacturing technologies and industry best practices.
• Mentor junior engineers and technical staff to foster continuous improvement and scientific rigor.

Conhecimentos

Process development

Scale-up

Validation

CAPA

GMP knowledge

Leadership

Formação académica

Chemical/Mechanical Engineering degree

Ferramentas

JMP

Minitab

Descrição da oferta de emprego

Placements24 seeks a Senior Process Development Engineer for a leading pharmaceutical manufacturer in Centurion, Gauteng. The role focuses on optimizing and scaling up manufacturing processes to ensure efficiency, quality, and cost-effectiveness.

You will design DoE studies, develop validation strategies, troubleshoot deviations, and drive technology transfer. Collaboration with R&D, QA, and Manufacturing is essential, with mentorship for junior engineers.