Senior Pharmaceutical Process Development Engineer

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical aid

Retirement contributions

Hybrid work model

Career development opportunities

Job summary

Placements24 in Port Elizabeth, Eastern Cape is seeking a Senior Pharmaceutical Process Development Engineer to optimize and scale up manufacturing processes for new and existing products. This hybrid role offers on-site collaboration at our Port Elizabeth facility.

The ideal candidate has a strong background in chemical/pharmaceutical engineering, 5+ years of process development experience, and proficiency with process simulation and GMP requirements.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
• Minimum of 5 years of experience in pharmaceutical process development and scale-up.
• Strong understanding of unit operations common in pharmaceutical manufacturing (e.g., filtration, drying, granulation, sterile processing).
• Experience with process simulation and modeling software.
• Proficiency in GMP and regulatory requirements for pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and project management skills.
• Strong written and verbal communication skills, with the ability to present technical information effectively.
• Experience with process validation and IQ/OQ/PQ.

Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes, focusing on efficiency, yield, purity, and cost-effectiveness.
• Scale-up processes from laboratory/pilot scale to commercial manufacturing, ensuring robustness and reproducibility.
• Identify and implement process improvements using statistical process control (SPC) and other methodologies.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Develop and execute process validation protocols and reports.
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure seamless technology transfer.
• Write clear and concise technical reports, SOPs, and batch records.
• Stay current with emerging technologies and best practices in pharmaceutical process engineering.
• Ensure all process development activities comply with GMP and relevant regulatory guidelines.
• Mentor junior engineers and provide technical guidance.

Skills

Analytical skills

Problem solving

Project management

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical Engineering

Tools

Process simulation software

Job description

About the Role Our client, a highly respected pharmaceutical manufacturer, is seeking a Senior Pharmaceutical Process Development Engineer to join their innovative team in **Port Elizabeth, Eastern Cape**. This role is pivotal in optimizing and scaling up manufacturing processes for new and existing pharmaceutical products. You will leverage your engineering expertise to ensure efficient, safe, and compliant production. The ideal candidate possesses a strong understanding of chemical engineering principles applied to pharmaceutical manufacturing, excellent problem-solving skills, and a commitment to quality. This hybrid role offers the flexibility to combine remote work with essential on-site collaboration at our **Port Elizabeth** facility, a key hub for our South African operations.

Key Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes, focusing on efficiency, yield, purity, and cost-effectiveness.
• Scale-up processes from laboratory/pilot scale to commercial manufacturing, ensuring robustness and reproducibility.
• Identify and implement process improvements using statistical process control (SPC) and other methodologies.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Develop and execute process validation protocols and reports.
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure seamless technology transfer.
• Write clear and concise technical reports, Standard Operating Procedures (SOPs), and batch records.
• Stay current with emerging technologies and best practices in pharmaceutical process engineering.
• Ensure all process development activities comply with GMP and relevant regulatory guidelines.
• Mentor junior engineers and provide technical guidance.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
• Minimum of 5 years of experience in pharmaceutical process development and scale-up.
• Strong understanding of unit operations common in pharmaceutical manufacturing (e.g., filtration, drying, granulation, sterile processing).
• Experience with process simulation and modeling software.
• Proficiency in GMP and regulatory requirements for pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and project management skills.
• Strong written and verbal communication skills, with the ability to present technical information effectively.
• Experience with process validation and IQ/OQ/PQ.
• Ability to work effectively in a team-oriented environment and manage cross-functional collaborations.

Benefits

• Our client offers a competitive salary, excellent benefits including medical aid and retirement contributions, and significant opportunities for professional development and career advancement within a growing organization.
• The hybrid work model offers a balance between remote flexibility and necessary on-site engagement.
• Join our **Port Elizabeth** team and contribute to producing high-quality medicines.