Senior Pharmaceutical Process Engineer

Placements24; Benoni; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health coverage

Retirement contributions

Generous vacation time

Job summary

Placements24 is seeking a Senior Pharmaceutical Process Engineer for our Benoni, Gauteng operations. The role focuses on optimizing and troubleshooting manufacturing processes for pharmaceutical products in a cGMP environment.

You will lead process improvements, validation, and technology transfer efforts to ensure safe, compliant production of high-quality medicines. The ideal candidate holds a Master’s in Chemical Engineering with 7+ years in pharma/biotech process engineering, and

Qualifications

• Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• Minimum 7 years of process engineering experience in pharma/biotech.
• Proven expertise in design, scale-up, validation, and optimization in a cGMP environment.
• Strong understanding of pharmaceutical manufacturing operations, equipment, and unit operations.
• Experience with process modeling software and DoE is a plus.
• Experience with quality risk management principles.
• Excellent problem-solving, analytical, and project management skills.
• Strong written and verbal communication; cross-functional collaboration.

Responsibilities

• Design, develop, and optimize manufacturing processes for pharmaceutical products, ensuring scalability and efficiency.
• Lead process validation activities, including protocol development, execution, and reporting.
• Troubleshoot manufacturing process deviations and implement CAPAs.
• Conduct PHAs and implement appropriate safety measures.
• Utilize engineering principles and statistical tools (Six Sigma, DoE) to improve process performance and product quality.
• Collaborate with R&D, Quality Assurance, and Production teams to support new product introductions and lifecycle management.
• Oversee technology transfer from laboratory to pilot plant and commercial manufacturing.
• Manage projects related to process upgrades, equipment installation, and facility modifications.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
• Develop and maintain SOPs and process documentation.
• Mentor junior engineers and provide technical guidance to manufacturing personnel.

Skills

Process design

Scale-up

Validation

CAPA

PHAs

Six Sigma

DoE

Project management

Cross-functional leadership

Communication

Education

Master's degree in Chemical Engineering

Tools

Process modeling software

Job description

About the Role

Our client, a distinguished pharmaceutical manufacturing company, is seeking an experienced Senior Pharmaceutical Process Engineer to enhance their operations in Benoni, Gauteng . This role is instrumental in optimizing and troubleshooting manufacturing processes for pharmaceutical products, ensuring efficiency, safety, and compliance with stringent regulatory standards. The ideal candidate will possess a strong background in chemical engineering principles, process design, scale-up, and validation within a cGMP environment. You will be responsible for leading process improvement initiatives, driving technological advancements, and ensuring the robust and consistent production of high-quality medicines. This position offers a significant opportunity to contribute to process excellence and innovation within the pharmaceutical industry in Benoni, Gauteng , working with a team dedicated to advancing healthcare.

Key Responsibilities

• Design, develop, and optimize manufacturing processes for pharmaceutical products, ensuring scalability and efficiency.
• Lead process validation activities, including protocol development, execution, and reporting.
• Troubleshoot manufacturing process deviations and implement effective corrective and preventive actions (CAPAs).
• Conduct process hazard analyses (PHAs) and implement appropriate safety measures.
• Utilize engineering principles and statistical tools (e.g., Six Sigma, DoE) to improve process performance and product quality.
• Collaborate with R&D, Quality Assurance, and Production teams to support new product introductions and lifecycle management.
• Oversee technology transfer activities from laboratory to pilot plant and commercial manufacturing.
• Manage projects related to process upgrades, equipment installation, and facility modifications.
• Ensure compliance with cGMP, FDA, EMA, and other relevant regulatory requirements.
• Develop and maintain Standard Operating Procedures (SOPs) and process documentation.
• Mentor junior engineers and provide technical guidance to manufacturing personnel.

Requirements

• Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• A minimum of 7 years of experience in process engineering within the pharmaceutical or biotechnology industry.
• Proven expertise in process design, scale-up, validation, and optimization in a cGMP environment.
• Strong understanding of pharmaceutical manufacturing operations, equipment, and unit operations.
• Experience with process modeling and simulation software is a plus.
• Proficiency in quality risk management principles and their application to process development.
• Excellent problem-solving, analytical, and project management skills.
• Strong written and verbal communication skills, with the ability to present technical information clearly.
• Demonstrated leadership capabilities and the ability to work effectively in cross-functional teams.
• Must be based in or willing to relocate to Benoni, Gauteng .

Benefits

Our client offers a competitive salary and an attractive benefits package, including comprehensive health coverage, retirement contributions, and generous vacation time. Opportunities for professional development, continuous learning, and career advancement are actively supported. Employees will have the chance to work on cutting-edge pharmaceutical manufacturing projects and contribute to the company's success. The position is located in Benoni, Gauteng , providing a dynamic work environment and the opportunity to be part of a company committed to producing life-changing medicines.