Senior Pharmaceutical Process Engineer

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

Benefits offered by this job

Health, dental, vision insurance

Retirement savings plan with employer

Hybrid work model

Career development opportunities

Paid time off

Job summary

Placements24 in Pietermaritzburg, SA seeks a Senior Pharmaceutical Process Engineer to optimize manufacturing processes and scale up production in a hybrid role with on-site and remote planning. You will lead validation activities, drive technology transfer, and collaborate with R&D, QA, and Production to ensure compliant operations.

The ideal candidate has 7+ years in pharma process engineering, strong GMP knowledge, and expertise in validation, scale-up, and process design.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or related discipline.
• 7+ years of experience in process engineering within pharma/biopharma.
• Knowledge of GMP, FDA/EMA guidelines and regulatory compliance.
• Experience with process validation, scale-up and technology transfer.
• Proficiency in process simulation (Aspen Plus) and CAD tools.
• Strong analytical, problem-solving and project management skills.

Responsibilities

• Design, develop and implement scalable pharmaceutical manufacturing processes.
• Optimize processes to improve yield, reduce costs and enhance quality.
• Lead IQ/OQ/PQ validation activities per GMP guidelines.
• Troubleshoot issues, identify root causes and implement corrective actions.
• Collaborate with R&D, QA and Production for tech transfer and integration.
• Develop and maintain SOPs and batch records for manufacturing.
• Conduct process hazard analyses and ensure safety compliance.
• Evaluate new technologies and equipment to enhance capabilities.
• Mentor junior engineers and manufacturing staff.

Skills

Pharma process engineering

Process design

Process validation

Scale-up

GMP compliance

Troubleshooting

Team collaboration

Education

Bachelor's or Master's in Chemical/Mechanical Eng

Tools

Aspen Plus

CAD tools

Job description

About the Role

Our client, a global leader in pharmaceutical manufacturing, is looking for an experienced Senior Pharmaceutical Process Engineer to join their esteemed team in **Pietermaritzburg, KwaZulu-Natal, ZA**. This role is critical for optimizing and scaling up manufacturing processes to ensure efficient, high-quality production of pharmaceutical products. The ideal candidate will possess a strong background in chemical engineering or a related field, with extensive experience in pharmaceutical process design, validation, and troubleshooting. This hybrid role allows for a blend of on-site operations at our **Pietermaritzburg** facility and remote strategic planning, offering a flexible approach to engineering excellence. You will play a key role in enhancing our manufacturing capabilities and ensuring compliance with international standards.

Key Responsibilities

• Design, develop, and implement new pharmaceutical manufacturing processes, ensuring scalability and efficiency.
• Optimize existing manufacturing processes to improve yield, reduce costs, and enhance product quality.
• Lead process validation activities, including IQ, OQ, and PQ, in compliance with GMP guidelines.
• Troubleshoot manufacturing issues, identify root causes, and implement effective corrective actions.
• Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless technology transfer and process integration.
• Develop and maintain Standard Operating Procedures (SOPs) and batch records for manufacturing processes.
• Conduct process hazard analyses and implement safety measures.
• Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities.
• Provide technical expertise and mentorship to junior engineers and manufacturing personnel.
• Ensure all activities comply with regulatory requirements (FDA, EMA, SAHPRA) and company quality standards.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related discipline.
• A minimum of 7 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
• In-depth knowledge of pharmaceutical manufacturing operations, including unit operations (e.g., granulation, compression, sterile filling, lyophilization).
• Proven experience with process validation, scale-up, and technology transfer.
• Strong understanding of GMP, FDA, EMA, and other relevant regulatory guidelines.
• Proficiency in process simulation software (e.g., Aspen Plus) and CAD tools is desirable.
• Excellent analytical, problem-solving, and project management skills.
• Effective communication and collaboration abilities.
• Experience with Lean Manufacturing or Six Sigma methodologies is a plus.

Benefits

• Our client offers a competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance coverage is provided.
• A generous retirement savings plan with employer match is available.
• This hybrid role offers a balance of on-site collaboration and remote strategic work.
• Opportunities for continuous learning, professional development, and career advancement within a leading pharmaceutical company are abundant.
• Paid time off and a supportive work environment are standard.