Senior Process Development Engineer

Placements24; Centurion; On-site; ZAR 1,100,000 - 1,600,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plan

Performance bonuses

Job summary

Placements24 seeks a Senior Process Development Engineer for a leading pharmaceutical manufacturer in Centurion, Gauteng. The role focuses on optimizing and scaling up manufacturing processes to ensure efficiency, quality, and cost-effectiveness.

You will design DoE studies, develop validation strategies, troubleshoot deviations, and drive technology transfer. Collaboration with R&D, QA, and Manufacturing is essential, with mentorship for junior engineers.

Qualifications

• Bachelor's or Master's degree in Chemical or Mechanical Engineering.
• 5–7 years within pharma process development/manufacturing.
• Experience in scale-up, validation.
• GMP/regulatory knowledge (FDA/EMA).
• Proficiency in JMP or Minitab for modeling.

Responsibilities

• Lead the development, optimization, and scale-up of pharmaceutical manufacturing processes (e.g., API synthesis, formulation, filling/finishing).
• Design experiments (DoE) to identify CPPs and establish robust operating ranges.
• Develop process validation strategies and execute validation protocols to demonstrate process reproducibility and reliability.
• Troubleshoot manufacturing process deviations and implement CAPAs.
• Collaborate with R&D, QA, and Manufacturing to ensure technology transfer and process implementation.
• Write and review process development reports, validation documents, and technical transfer packages.
• Ensure all process development and manufacturing activities comply with GMP and relevant regulatory requirements.
• Stay current with advancements in pharmaceutical manufacturing technologies and industry best practices.
• Mentor junior engineers and technical staff to foster continuous improvement and scientific rigor.

Skills

Process development

Scale-up

Validation

CAPA

GMP knowledge

Leadership

Education

Chemical/Mechanical Engineering degree

Tools

JMP

Minitab

Job description

About the Role

Our client, a major pharmaceutical manufacturer with a strong global presence, is seeking an experienced Senior Process Development Engineer to join their dynamic manufacturing operations in Centurion, Gauteng, ZA . This role is crucial for optimizing and scaling up pharmaceutical manufacturing processes to ensure efficiency, quality, and cost-effectiveness. The ideal candidate will possess a strong engineering background, coupled with extensive experience in pharmaceutical process development, validation, and troubleshooting. You will be responsible for designing, implementing, and improving manufacturing processes for various pharmaceutical products. This is an exceptional opportunity to contribute to the production of vital medicines within a cutting-edge facility. We are looking for a forward-thinking individual with excellent problem-solving skills and a commitment to upholding the highest manufacturing standards. Your expertise will be vital in driving operational excellence and ensuring the successful delivery of high-quality pharmaceutical products. This role offers significant scope for innovation and professional growth.

Key Responsibilities

• Lead the development, optimization, and scale-up of pharmaceutical manufacturing processes (e.g., API synthesis, formulation, filling/finishing).
• Design experiments (DoE) to identify critical process parameters (CPPs) and establish robust operating ranges.
• Develop process validation strategies and execute validation protocols to demonstrate process reproducibility and reliability.
• Troubleshoot manufacturing process deviations and implement effective corrective and preventive actions (CAPAs).
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure seamless technology transfer and process implementation.
• Write and review process development reports, validation documents, and technical transfer packages.
• Ensure all process development and manufacturing activities comply with GMP and relevant regulatory requirements.
• Stay current with advancements in pharmaceutical manufacturing technologies and industry best practices.
• Mentor junior engineers and technical staff, fostering a culture of continuous improvement and scientific rigor.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
• A minimum of 5-7 years of experience in process development and/or manufacturing within the pharmaceutical or biopharmaceutical industry.
• Proven experience in process scale-up, optimization, and validation.
• Strong understanding of GMP, regulatory requirements (e.g., FDA, EMA), and quality systems.
• Proficiency in process modeling, simulation, and statistical analysis tools (e.g., JMP, Minitab).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong leadership and project management capabilities.
• Exceptional written and verbal communication skills.
• Ability to work effectively in a multidisciplinary team environment.

Benefits

Our client offers a competitive salary, comprehensive benefits package including health insurance, retirement savings plan, and performance bonuses. This role provides significant opportunities for professional development, continuous learning, and career advancement within a leading pharmaceutical organization located in Centurion, Gauteng, ZA .