Hybrid Pharma Process Engineer | Scale-Up & Validation

Placements24; United States; Híbrido; USD 54.000 - 91.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical aid

Life insurance

Retirement annuity

Hybrid work arrangement

Descripción de la vacante

Placements24 is seeking a Pharmaceutical Process Engineer to optimize manufacturing processes in a regulated pharma setting. You will lead scale-up efforts, validate processes (IQ/OQ/PQ), and collaborate across R&D, QA, and Production to ensure compliant, efficient operations.

The role emphasizes process design, troubleshooting, documentation, and staying current with industry best practices within a hybrid environment in South Africa.

Formación

• Bachelor's or Master's degree in Chemical or Mechanical Engineering.
• 5+ years of process engineering experience in pharma or a regulated industry.
• Strong knowledge of GMP, IQ/OQ/PQ validation, and regulatory requirements.
• Experience in process optimization, troubleshooting and scale-up.
• Familiar with unit operations such as granulation, blending, tablet filling.
• Excellent analytical and project management skills.
• Strong communication and teamwork abilities.

Responsabilidades

• Analyze current pharmaceutical manufacturing processes to identify efficiency gains.
• Design, develop, and implement process modifications and new technologies.
• Lead process validation activities (IQ, OQ, PQ) and ensure regulatory compliance.
• Troubleshoot production issues, identify root causes, implement solutions.
• Develop and maintain SOPs, batch records, and technical reports.
• Collaborate with R&D, QA, and Production to transfer and scale processes.
• Ensure adherence to GMP, safety, and environmental regulations.
• Stay updated on new technologies and best practices in pharmaceutical manufacturing.
• Participate in process hazard analyses and risk assessments.
• Train production personnel on new or modified processes.

Conocimientos

Process optimization

Scale-up

GMP compliance

IQ/OQ/PQ validation

Process simulation

Cross-functional collaboration

Project management

LEAN/Six Sigma

Troubleshooting

Educación

Bachelor's or Master's in Chemical or Mechanical Engineering

Herramientas

Aspen Plus

CAD

Descripción del empleo

Placements24 is seeking a Pharmaceutical Process Engineer to optimize manufacturing processes in a regulated pharma setting. You will lead scale-up efforts, validate processes (IQ/OQ/PQ), and collaborate across R&D, QA, and Production to ensure compliant, efficient operations.

The role emphasizes process design, troubleshooting, documentation, and staying current with industry best practices within a hybrid environment in South Africa.