Lead Pharmaceutical Process Engineer

Placements24; George; On-site; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary and bonus structure

Medical, dental, and vision coverage

Generous annual leave and holidays

Retirement savings plan with employer

Job summary

Placements24 is seeking an experienced Lead Pharmaceutical Process Engineer to oversee and optimize manufacturing processes at a state-of-the-art facility in George. You will lead a team of engineers and technicians, drive process development from pilot to production, and ensure GMP-compliant operations across all manufacturing stages.

The ideal candidate has a strong background in chemical/pharmaceutical engineering, extensive process design experience, and a track record of improving

Qualifications

• Master's or Ph.D. in Chemical Engineering, Pharmaceutical Engineering, or closely related field.
• At least 8 years of progressive pharmaceutical process engineering experience, with 3+ years in a leadership or supervisory role.
• Demonstrated expertise in process design, scale-up, validation, and technology transfer.
• Thorough understanding of GMP, ICH guidelines, and regulatory requirements for pharmaceutical manufacturing.
• Experience with lean manufacturing principles and Six Sigma is a plus.

Responsibilities

• Lead the design, development, and optimization of pharmaceutical manufacturing processes from pilot scale to commercial production.
• Manage and mentor a team of process engineers and technicians, fostering a culture of collaboration and continuous improvement.
• Oversee process validation activities, ensuring compliance with GMP, FDA, and other relevant regulatory requirements.
• Develop and implement Standard Operating Procedures (SOPs) for all manufacturing processes.
• Troubleshoot and resolve complex process-related issues, identifying root causes and implementing CAPA.
• Conduct process hazard analyses and implement safety measures to ensure a safe working environment.
• Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities and efficiency.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Production to ensure seamless process integration and product quality.
• Monitor KPIs and drive initiatives for efficiency gains and cost reduction.

Skills

Leadership

Process design

GMP knowledge

Aspen Plus

Statistical analysis

Education

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

Tools

Aspen Plus

Job description

About the Role

Our client, a pioneering pharmaceutical manufacturer, is seeking an experienced and visionary Lead Pharmaceutical Process Engineer to oversee and optimize manufacturing processes at their state-of-the-art facility in George. This critical role involves leading a team of engineers and technicians in the design, development, implementation, and continuous improvement of pharmaceutical production processes. The successful candidate will be instrumental in ensuring high-efficiency, quality, and cost-effectiveness in all manufacturing operations, adhering strictly to international regulatory standards. This is a significant opportunity to shape the future of pharmaceutical production within a respected organization known for its commitment to innovation and excellence.

Key Responsibilities

• Lead the design, development, and optimization of pharmaceutical manufacturing processes from pilot scale to commercial production.


• Manage and mentor a team of process engineers and technicians, fostering a culture of collaboration and continuous improvement.


• Oversee process validation activities, ensuring compliance with GMP, FDA, and other relevant regulatory requirements.


• Develop and implement Standard Operating Procedures (SOPs) for all manufacturing processes.


• Troubleshoot and resolve complex process-related issues, identifying root causes and implementing corrective and preventive actions (CAPA).


• Conduct process hazard analyses and implement safety measures to ensure a safe working environment.


• Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities and efficiency.


• Collaborate with cross-functional teams including R&D, Quality Assurance, and Production to ensure seamless process integration and product quality.


• Monitor key process performance indicators (KPIs) and drive initiatives for efficiency gains and cost reduction.

Requirements

• Master's or Ph.D. degree in Chemical Engineering, Pharmaceutical Engineering, or a closely related field.


• A minimum of 8 years of progressive experience in pharmaceutical process engineering, with at least 3 years in a leadership or supervisory role.


• Demonstrated expertise in pharmaceutical process design, scale-up, validation, and technology transfer.


• Thorough understanding of GMP, ICH guidelines, and regulatory requirements for pharmaceutical manufacturing.


• Strong knowledge of various pharmaceutical dosage forms and their manufacturing processes (e.g., solid dosage, sterile injectables).


• Excellent leadership, team management, and communication skills.


• Proficiency in process simulation software (e.g., Aspen Plus) and statistical analysis tools.


• Experience with lean manufacturing principles and Six Sigma methodologies is a plus.

Benefits

• Highly competitive salary and comprehensive bonus structure.


• Extensive medical, dental, and vision coverage.


• Generous annual leave and company holidays.


• Retirement savings plan with employer match.


• Professional development funding and opportunities for advanced training.


• Relocation assistance may be provided for qualified candidates.


• Access to cutting-edge technology and a collaborative research environment.