Senior Process Development Engineer for Pharma Scale-Up

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement savings plan with company 


Generous paid time off

Relocation assistance

Job summary

Placements24 is seeking a highly skilled Lead Process Development Engineer for its George, Western Cape facility. You will spearhead process optimization from lab scale to commercial production and lead a team of engineers and technicians dedicated to robust, compliant manufacturing.

You will drive process validation, troubleshoot complex issues, and implement continuous improvement with Lean Six Sigma, ensuring regulatory alignment with GMP and FDA standards.

Qualifications

• Bachelor's or Master's degree in Chemical or Mechanical Engineering or related field.
• Minimum 8 years of progressive experience in pharmaceutical process development and manufacturing.
• Proven experience in leading engineering teams and managing complex projects.
• In-depth knowledge of GMP, FDA, and other regulatory requirements.
• Strong understanding of unit operations relevant to pharmaceutical production (e.g., filtration, drying, milling, granulation).
• Experience with process simulation software and statistical analysis tools.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional leadership and communication abilities.

Responsibilities

• Lead design, development, and optimization of pharmaceutical processes from lab to commercial production.
• Manage and mentor a team of process engineers and technicians.
• Develop and implement process validation strategies ensuring regulatory compliance.
• Troubleshoot manufacturing issues, identify root causes, implement corrective actions.
• Conduct feasibility studies and technical assessments for new products and process changes.
• Collaborate with R&D, QA, and Manufacturing Operations teams.
• Author and review technical reports and SOPs.
• Drive continuous improvement using Lean Six Sigma methodologies.
• Oversee process safety assessments and compliance with HSE regulations.
• Manage external vendors and contractors for equipment installation and commissioning.

Skills

Leadership

Team mentoring

Project management

Problem solving

Communication

Lean Six Sigma

Regulatory knowledge

GMP knowledge

Aseptic processing familiarity

Education

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

Tools

Process simulation software

Statistical analysis tools

Job description

Placements24 is seeking a highly skilled Lead Process Development Engineer for its George, Western Cape facility. You will spearhead process optimization from lab scale to commercial production and lead a team of engineers and technicians dedicated to robust, compliant manufacturing.

You will drive process validation, troubleshoot complex issues, and implement continuous improvement with Lean Six Sigma, ensuring regulatory alignment with GMP and FDA standards.