Senior Pharma Process Engineer - Scale-Up & cGMP

Placements24

Benoni

On-site

ZAR 1,200,000 - 1,800,000

Full time

13 hours ago
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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

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

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