Senior Process Development Engineer (Remote)

Placements24; Mbombela (Nelspruit); Híbrido; ZAR 1.000.000 - 1.800.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance bonus

Health insurance

Retirement plan

Home office allowance

Flexible hours

Training & conferences

Remote autonomy

Descripción de la vacante

Placements24 is recruiting a Senior Process Development Engineer to join a pioneering pharmaceutical company. This fully remote role focuses on optimizing and scaling manufacturing processes for novel products, ensuring GMP compliance and regulatory readiness.

You will lead process development, scale-up from pilot to commercial, transfer technology, and collaborate with R&D, manufacturing, and QA to translate lab processes into robust operations.

Formación

• Master's degree or PhD in Chemical Engineering or a related discipline.
• Minimum 7 years of progressive experience in process development and engineering within the Pharmaceutical or biopharmaceutical industry.
• Strong understanding of chemical reaction engineering, mass transfer, heat transfer, and fluid dynamics.
• Proven experience with process scale-up, technology transfer, and validation (IQ/OQ/PQ).
• In-depth knowledge of GMP regulations and guidelines relevant to pharmaceutical manufacturing.
• Experience with process simulation software and data analysis tools.
• Excellent problem-solving, analytical, and project management skills.
• Strong written and verbal communication abilities, with experience in technical documentation.
• Ability to work effectively and autonomously in a remote setting.
• Experience in sterile manufacturing or solid dosage form process development is a plus.

Responsabilidades

• Lead process development and optimization initiatives for new and existing pharmaceutical manufacturing processes.
• Perform process design, scale-up, and technology transfer activities from pilot to commercial scale.
• Develop and validate manufacturing processes in accordance with GMP and regulatory requirements.
• Troubleshoot and resolve technical issues related to process performance and equipment.
• Conduct process hazard analyses and implement safety measures.
• Define critical process parameters (CPPs) and establish control strategies to ensure consistent product quality.
• Collaborate with equipment vendors to specify, procure, and qualify process equipment.
• Prepare detailed technical reports, batch records, and validation documentation.
• Stay abreast of new technologies and best practices in pharmaceutical process development and manufacturing.
• Mentor junior engineers and contribute to the continuous improvement of engineering processes and standards.

Conocimientos

Process development

Scale-up

GMP knowledge

Data analysis

Problem solving

Project management

Communication

Remote work

Educación

Master's degree or PhD in Chemical Engineering or related discipline

Herramientas

Process simulation software

IQ/OQ/PQ documentation

Descripción del empleo

About the Role

Our client, a pioneering **Pharmaceutical** company committed to advancing global health, is seeking an experienced Senior Process Development Engineer to join their fully remote engineering team. This role is crucial for optimizing and scaling up manufacturing processes for novel **Pharmaceutical** products, ensuring efficiency, quality, and regulatory compliance. The ideal candidate will possess extensive knowledge of chemical engineering principles, process scale-up, validation, and Good Manufacturing Practices (GMP). You will collaborate closely with R&D, manufacturing, and quality assurance teams to translate laboratory processes into robust, commercial-scale operations. This is an exciting opportunity to contribute to the development of life-saving medications from a remote work environment, driving innovation and ensuring the reliable supply of critical treatments. Join our dedicated remote team and help shape the future of **Pharmaceutical** manufacturing.

Key Responsibilities

• Lead process development and optimization initiatives for new and existing **Pharmaceutical** manufacturing processes.
• Perform process design, scale-up, and technology transfer activities from pilot to commercial scale.
• Develop and validate manufacturing processes in accordance with GMP and regulatory requirements.
• Troubleshoot and resolve technical issues related to process performance and equipment.
• Conduct process hazard analyses and implement safety measures.
• Define critical process parameters (CPPs) and establish control strategies to ensure consistent product quality.
• Collaborate with equipment vendors to specify, procure, and qualify process equipment.
• Prepare detailed technical reports, batch records, and validation documentation.
• Stay abreast of new technologies and best practices in pharmaceutical process development and manufacturing.
• Mentor junior engineers and contribute to the continuous improvement of engineering processes and standards.

Requirements

• Master's degree or PhD in Chemical Engineering or a related discipline.
• Minimum of 7 years of progressive experience in process development and engineering within the **Pharmaceutical** or biopharmaceutical industry.
• Strong understanding of chemical reaction engineering, mass transfer, heat transfer, and fluid dynamics.
• Proven experience with process scale-up, technology transfer, and validation (IQ/OQ/PQ).
• In-depth knowledge of GMP regulations and guidelines relevant to pharmaceutical manufacturing.
• Experience with process simulation software and data analysis tools.
• Excellent problem-solving, analytical, and project management skills.
• Strong written and verbal communication abilities, with experience in technical documentation.
• Ability to work effectively and autonomously in a remote setting.
• Experience in sterile manufacturing or solid dosage form process development is a plus.

Benefits

• Highly competitive salary and performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance plans.
• Retirement savings plan with generous company matching.
• Significant home office setup allowance and ongoing tech support.
• Flexible work hours and a commitment to work-life balance.
• Opportunities for professional development, training, and attending industry conferences.
• Be part of a mission-driven company developing life-changing **Pharmaceutical** products.
• Enjoy the autonomy and flexibility of a remote work arrangement.