Senior Process Development Engineer

Placements24; Paarl; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary package

Performance bonuses

Medical aid, retirement fund, life 보험

Professional development opportunities

Annual leave and sick leave

Job summary

Placements24 is seeking a Senior Process Development Engineer for our client’s advanced pharma manufacturing facility in Paarl, Western Cape. The role focuses on optimizing and scaling up manufacturing processes to ensure efficiency, quality, and cost-effectiveness across the product lifecycle.

You will lead hands-on development, validation, and tech transfer activities, collaborating with R&D, QA/QC, and production teams while adhering to cGMP, safety, and environmental regulations.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• 5–7 years of experience in process development and scale-up in pharmaceutical/biopharmaceutical industries.
• Proven track record of process optimization and validation.
• Strong understanding of cGMP, FDA, and EMA regulations.
• Experience with PAT and SPC is advantageous.

Responsibilities

• Develop, optimize, and scale-up pharmaceutical processes from laboratory to commercial scale.
• Design experiments to evaluate process parameters and identify CPCs.
• Conduct PHAs and implement safety measures.
• Develop and execute process validation protocols and reports.
• Troubleshoot manufacturing issues to minimize downtime and ensure product quality.
• Collaborate with R&D, QA/QC, and production teams to ensure seamless technology transfer and process implementation.
• Maintain comprehensive documentation of process development activities, including batch records and technical reports.
• Stay abreast of new manufacturing technologies and industry best practices.
• Ensure all activities comply with cGMP, safety, and environmental regulations.
• Mentor junior engineers and technicians, providing technical guidance and support.

Skills

Problem-solving

Analytical skills

Project management

Education

Bachelor's or Master's degree in Chemical Engineering

Tools

Process Analytical Technology (PAT)

Statistical Process Control (SPC)

Job description

About the Role Our client, a leading pharmaceutical manufacturer, is seeking a highly experienced Senior Process Development Engineer for their facility in Paarl, Western Cape . This role is critical in optimizing and scaling up manufacturing processes for pharmaceutical products, ensuring efficiency, quality, and cost-effectiveness. The successful candidate will work on improving existing processes and developing new ones for innovative drug products. This hands-on role requires a deep understanding of chemical engineering principles, process validation, and GMP requirements. Join a team dedicated to excellence in pharmaceutical manufacturing in the beautiful Western Cape region.

Key Responsibilities

• Develop, optimize, and scale-up pharmaceutical manufacturing processes from laboratory to commercial scale.
• Design and execute experiments to evaluate process parameters and identify critical process controls (CPCs).
• Conduct process hazard analyses (PHAs) and implement appropriate safety measures.
• Develop and execute process validation protocols and reports.
• Troubleshoot manufacturing issues and implement effective solutions to minimize downtime and ensure product quality.
• Collaborate with R&D, QA/QC, and production teams to ensure seamless technology transfer and process implementation.
• Maintain comprehensive documentation of process development activities, including batch records and technical reports.
• Stay abreast of new manufacturing technologies and industry best practices.
• Ensure all activities comply with cGMP, safety, and environmental regulations.
• Mentor junior engineers and technicians, providing technical guidance and support.

Requirements

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• Minimum of 5-7 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
• Proven track record of successful process optimization and validation.
• Strong understanding of chemical engineering principles, reaction kinetics, and mass transfer.
• In-depth knowledge of cGMP, FDA, and EMA regulations relevant to pharmaceutical manufacturing.
• Experience with process analytical technology (PAT) and statistical process control (SPC) is advantageous.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong project management and organizational abilities.
• Effective communication and interpersonal skills, with the ability to collaborate across departments.
• Experience working in a manufacturing environment in Paarl .

Benefits

• Our client offers a competitive salary package, performance bonuses, and comprehensive benefits including medical aid, retirement fund contributions, and life insurance.
• Opportunities for continuous learning, professional development, and career advancement are readily available.
• Paid time off includes annual leave and sick leave.
• This role is based at our advanced manufacturing facility in Paarl, Western Cape, ZA .