Process Development Engineer - Pharmaceutical Manufacturing

Placements24; Vereeniging; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Salary bonus

Medical aid

Retirement fund

Paid leave

Professional development

Career growth

Wellness programs

Job summary

Placements24 in Vereeniging, Gauteng, is seeking a Process Development Engineer to optimize and scale pharmaceutical manufacturing. You will partner with R&D, QA and Production to design robust processes, implement DoE analyses, and ensure cGMP compliance across scale-up activities.

The role blends hands-on plant work with data-driven remote analysis, documenting validations (IQ/OQ/PQ) and driving continuous improvements.

Qualifications

• BS/BE in a relevant engineering field with 4+ years pharma experience.
• Solid knowledge of cGMP and regulatory expectations.
• Experience with process validation and continuous improvement.

Responsibilities

• Design, develop, optimize, and scale-up pharma manufacturing processes.
• Conduct DoE studies and document IQ/OQ/PQ validations.
• Troubleshoot deviations and implement CAPAs.
• Collaborate with R&D, QA, and Production for tech transfer.
• Develop batch records, SOPs, and process diagrams.

Skills

Process development

Scale-up

DoE (Design of Experiments)

cGMP knowledge

Process validation

Data analysis

Cross-functional collaboration

Project management

Troubleshooting

Statistical tools

Education

Bachelor's degree in Chemical/Mechanical/Pharmaceutical Engineering

Master's degree (advantageous)

Tools

Process modeling software

DoE software

Job description

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking a talented Process Development Engineer to join their innovative team in Vereeniging, Gauteng. This role is crucial for optimizing and scaling up manufacturing processes to ensure the efficient and high-quality production of pharmaceutical products. The Process Development Engineer will work closely with R&D, production, and quality assurance teams to troubleshoot issues, implement improvements, and ensure processes meet stringent regulatory and operational standards. This is an excellent opportunity for an engineer with a passion for process optimization and a desire to contribute to the pharmaceutical industry's advancements. The hybrid model allows for essential hands-on work in the facility combined with focused remote analysis and documentation, ensuring a productive and balanced work experience in the Vereeniging area.

Key Responsibilities

• Design, develop, optimize, and scale-up pharmaceutical manufacturing processes, ensuring efficiency, robustness, and compliance.
• Conduct process validation studies, including IQ, OQ, and PQ, and prepare associated documentation.
• Troubleshoot manufacturing process deviations and implement effective corrective and preventive actions (CAPAs).
• Utilize engineering principles and statistical tools (e.g., Design of Experiments - DoE) to identify and implement process improvements.
• Collaborate with cross-functional teams, including Research & Development, Quality Assurance, and Production, to ensure seamless technology transfer and process implementation.
• Develop and maintain process documentation, including batch records, SOPs, and PFDs/P&IDs.
• Evaluate new technologies and equipment for potential implementation in manufacturing processes.
• Ensure all process development activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory requirements.
• Contribute to the design and setup of new manufacturing lines and equipment.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related field. A Master's degree is advantageous.
• Minimum of 4 years of experience in process development, scale-up, or manufacturing within the pharmaceutical industry.
• Strong understanding of cGMP regulations and pharmaceutical manufacturing principles.
• Proven experience with process validation, troubleshooting, and continuous improvement methodologies.
• Proficiency in process modeling, simulation, and data analysis tools.
• Excellent analytical and problem-solving skills with meticulous attention to detail.
• Strong written and verbal communication skills, with the ability to present technical information clearly.
• Experience with project management and cross-functional team collaboration.
• Familiarity with various pharmaceutical dosage forms and their manufacturing processes is a plus.

Benefits

• Competitive salary and performance-based bonus opportunities.
• Comprehensive medical aid and retirement fund contributions.
• Generous annual leave and sick leave benefits.
• Professional development programs and support for further education.
• Access to advanced manufacturing technologies and facilities.
• A collaborative work environment focused on innovation and quality.
• Opportunities for career growth within a leading pharmaceutical organization.
• Wellness programs and employee assistance services.