Pharmaceutical Process Development Engineer

Placements24; LegKraal Gate; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Retirement savings plan

Generous paid time off

Job summary

Placements24 is seeking a Pharmaceutical Process Development Engineer for our client’s Mahikeng, North West facility. This hybrid role involves designing, validating, and optimizing scalable production processes for solid dosage forms and sterile products.

You will work with R&D, engineering, and QA teams to drive technology transfer, CAPAs, and continuous improvement while ensuring GMP compliance and regulatory standards.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Mechanical Engineering, or related field.
• Minimum of 4 years of experience in process development and validation within the pharmaceutical manufacturing industry.
• Experience with solid dosage form manufacturing and/or sterile product manufacturing.
• Strong GMP, FDA, and ICH knowledge related to pharmaceutical manufacturing.
• Proficiency in process modeling software and data analysis tools.
• Excellent problem-solving, analytical, and communication skills.
• Strong project management and ability to manage multiple projects.

Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes for scaling and robustness.
• Develop and execute process validation protocols and reports per GMP/regulatory guidelines.
• Troubleshoot deviations and implement CAPAs.
• Conduct process capability studies and seek continuous improvement opportunities.
• Collaborate with R&D, engineering, and QA on technology transfer.
• Evaluate and recommend new manufacturing technologies and equipment.
• Develop process models and simulations to predict performance.
• Prepare process descriptions, URS, and IQ/OQ/PQ plans.
• Ensure safety, environmental, and regulatory compliance in activities.
• Train manufacturing personnel on new processes and equipment.

Skills

Problem solving

Project management

Analytical thinking

Communication

Team collaboration

Lean Six Sigma

Education

Bachelors/Masters in Chemical/Pharmaceutical/Mechanical Eng

Tools

Process modeling software

Data analysis tools

Job description

About the Role

Our client, a leading pharmaceutical manufacturer known for its commitment to quality and innovation, is seeking a skilled Pharmaceutical Process Development Engineer to join their dynamic manufacturing sciences team. This role is critical in optimizing and scaling up pharmaceutical manufacturing processes to ensure efficiency, reproducibility, and compliance with stringent regulatory standards. You will work on process design, validation, troubleshooting, and continuous improvement initiatives for both solid dosage forms and sterile products. The position is located at our advanced facility in **Mahikeng, North West**, providing a state-of-the-art environment for innovation. This hybrid role balances essential hands-on process work with remote analysis and collaborative planning. We foster a culture of scientific rigor and operational excellence.

Key Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes for new and existing products, focusing on scalability and robustness.
• Develop and execute process validation protocols and reports, ensuring compliance with GMP and regulatory guidelines.
• Troubleshoot process deviations and implement effective corrective and preventive actions (CAPAs).
• Conduct process capability studies and identify opportunities for continuous improvement.
• Collaborate with R&D, engineering, and quality assurance teams on technology transfer activities.
• Evaluate and recommend new manufacturing technologies and equipment.
• Develop process models and simulations to predict and optimize process performance.
• Prepare technical documentation, including process descriptions, URS, and IQ/OQ/PQ plans.
• Ensure all process development activities align with safety, environmental, and regulatory requirements.
• Train manufacturing personnel on new processes and equipment.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Mechanical Engineering, or a related field.
• Minimum of 4 years of experience in process development and validation within the pharmaceutical manufacturing industry.
• Proven experience with solid dosage form manufacturing processes (e.g., granulation, tableting, coating) and/or sterile product manufacturing (e.g., aseptic filling, lyophilization).
• Strong understanding of GMP, FDA, and ICH guidelines related to pharmaceutical manufacturing.
• Proficiency in process modeling software and data analysis tools.
• Excellent problem-solving and analytical skills.
• Strong project management capabilities and the ability to manage multiple projects simultaneously.
• Effective communication and interpersonal skills, with the ability to collaborate across departments.
• Experience with URS, IQ, OQ, and PQ development and execution.
• Familiarity with Lean Manufacturing or Six Sigma principles is a plus.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive medical, dental, and vision insurance plans.
• Retirement savings plan with company contribution.
• Generous paid time off and holiday schedule.
• Opportunities for professional growth and specialized training.
• Access to advanced manufacturing technologies and facilities.
• A collaborative and forward-thinking work culture.
• Relocation assistance may be available.