Chemical Engineer - Pharmaceutical Process Development

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

Benefits offered by this job

Competitive salary

Health insurance

Dental insurance

Vision insurance

Generous annual leave

Retirement plan

Professional development

Relocation assistance

Job summary

Placements24 is seeking a seasoned Chemical Engineer to join our Process Development team in Port Elizabeth, Eastern Cape. The role focuses on optimizing and scaling up manufacturing processes for APIs and intermediates, ensuring regulatory compliance and robust process validation.

You will work hands-on in advanced facilities, driving collaboration with R&D, QA, and production to deliver high-quality medicines safely and efficiently.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering from an accredited institution.
• Minimum 5 years in pharmaceutical process development.
• Experience with API synthesis, crystallization, filtration, drying, and formulation.
• Knowledge of cGMP and FDA/EMA guidelines.

Responsibilities

• Develop, optimize, and scale-up chemical processes for the synthesis and purification of pharmaceutical intermediates and APIs.
• Design and execute experiments to understand process parameters and identify critical quality attributes.
• Conduct process validation studies, ensuring compliance with cGMP and regulatory requirements.
• Troubleshoot manufacturing issues and implement CAPAs.
• Collaborate with cross-functional teams, including analytical development, formulation, and manufacturing operations.
• Prepare technical documentation, including batch records, validation reports, and process descriptions.
• Evaluate and implement new process technologies to enhance efficiency, yield, and product quality.
• Ensure all laboratory and plant operations adhere to stringent safety and environmental protocols.

Skills

Chemical engineering

Process development

Scale-up

cGMP knowledge

Regulatory compliance

Analytical skills

Education

Bachelor's or Master's in Chemical Engineering

Tools

Process simulation software

Job description

About the Role

Our client, a rapidly growing pharmaceutical company renowned for its innovative drug development pipeline, is seeking a talented Chemical Engineer to join their Process Development team in Port Elizabeth, Eastern Cape . This role is crucial for the optimization and scale-up of manufacturing processes for new drug products. You will work hands-on in state-of-the-art facilities, applying chemical engineering principles to solve complex challenges in API (Active Pharmaceutical Ingredient) synthesis and formulation. The ideal candidate possesses a strong background in pharmaceutical manufacturing, process validation, and regulatory compliance. You will collaborate closely with R&D scientists, quality assurance, and production teams to ensure the efficient and safe production of high-quality medicines. This is a hands-on role requiring your physical presence in our Port Elizabeth facility to ensure optimal collaboration and direct oversight of critical processes. Your contributions will directly impact the availability of life-saving therapies to patients worldwide. This position offers a significant opportunity to grow your career within a leading pharmaceutical organization.

Key Responsibilities

• Develop, optimize, and scale-up chemical processes for the synthesis and purification of pharmaceutical intermediates and APIs.
• Design and execute experiments to understand process parameters and identify critical quality attributes.
• Conduct process validation studies, ensuring compliance with cGMP (current Good Manufacturing Practices) and regulatory requirements.
• Troubleshoot manufacturing issues and implement corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams, including analytical development, formulation, and manufacturing operations.
• Prepare technical documentation, including batch records, validation reports, and process descriptions.
• Evaluate and implement new process technologies to enhance efficiency, yield, and product quality.
• Ensure all laboratory and plant operations adhere to stringent safety and environmental protocols.

Requirements

• Bachelor's or Master's degree in Chemical Engineering from an accredited institution.
• A minimum of 5 years of experience in process development within the pharmaceutical or biotechnology industry.
• Strong understanding of API synthesis, crystallization, filtration, drying, and formulation processes.
• Proven experience with process validation, scale-up, and technology transfer.
• Familiarity with cGMP regulations and FDA/EMA guidelines.
• Excellent analytical and problem-solving skills.
• Proficiency in using laboratory equipment and process simulation software.
• Strong communication and teamwork skills, essential for effective collaboration within the facility.

Benefits

• Competitive salary and potential for annual bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous annual leave and sick leave policy.
• Retirement savings plan with company contribution.
• Opportunities for continuous learning and professional development.
• Access to cutting-edge pharmaceutical manufacturing technologies.
• Career advancement opportunities within a growing organization.
• Relocation assistance may be available for qualified candidates.