Senior Pharmaceutical Process Development Engineer

Placements24; Mtubatuba Local Municipality; Hybrid; ZAR 800,000 - 1,200,000; Full time

Benefits offered by this job

Medical insurance

Retirement savings plan

Performance incentives

Generous paid time off

Professional development

Life insurance and disability coverage

Job summary

Placements24 is seeking a Senior Pharmaceutical Process Development Engineer in Richards Bay, KwaZulu-Natal. The role focuses on development, optimization and scale-up of manufacturing processes for new and existing products, ensuring efficient, robust, and compliant methods in a hybrid work setting.

The candidate should have a strong engineering background with 7+ years in pharmaceutical manufacturing, experience with solid dosage forms or sterile products, and a track record in process

Qualifications

• Bachelor's or Master's in Chemical Engineering, Mechanical Engineering or Pharmaceutical Sciences.
• 7+ years of experience in pharmaceutical process development and scale-up.
• Solid dosage forms and/or sterile drug product manufacturing experience.
• Proficiency in process modeling, simulation and statistical analysis software.
• Strong GMP, FDA/EMA regulations and validation principles knowledge.
• Experience with IQ/OQ/PQ and technology transfer.
• Excellent problem-solving, analytical and leadership skills.

Responsibilities

• Lead development and optimization of pharma manufacturing processes (formulation, granulation, tableting, coating, sterile fill-finish).
• Design and execute experiments for process characterization, scale-up, and tech transfer.
• Use PAT and SPC to monitor and improve process performance.
• Develop and validate process equipment and systems per GMP standards.
• Troubleshoot process-related issues to minimize production disruption.
• Author process development reports, validation protocols and batch records.
• Collaborate with R&D, QA and Manufacturing for seamless integration of new processes.
• Stay updated on new manufacturing technologies and approaches.

Skills

Process modeling

Simulation

Statistical analysis

Automation

Project management

Leadership

Problem solving

Education

Bachelor's or Master's in Chemical Engineering, Mechanical Engineering, or Pharmaceutical Sciences

Job description

About the Role

Our client, a forward-thinking pharmaceutical manufacturer situated in Richards Bay, KwaZulu-Natal , is looking for a highly skilled Senior Pharmaceutical Process Development Engineer to join their innovative team. This critical role focuses on the development, optimization, and scale-up of manufacturing processes for new and existing pharmaceutical products. You will play a key part in ensuring efficient, robust, and compliant production methods, driving cost-effectiveness and product quality. This position adopts a hybrid work model, allowing for a blend of hands-on work in our state-of-the-art facilities and remote analysis and reporting. The successful candidate will possess a strong engineering background with extensive experience in pharmaceutical manufacturing environments. This is an excellent opportunity to lead process development initiatives and make a tangible impact in a thriving industry.

Key Responsibilities

• Lead the development and optimization of pharmaceutical manufacturing processes, including formulation, granulation, tableting, coating, and sterile fill-finish operations.
• Design and execute experiments for process characterization, scale-up studies, and technology transfer.
• Utilize process analytical technology (PAT) and statistical process control (SPC) to monitor and improve process performance.
• Develop and validate process equipment and manufacturing systems according to GMP and industry standards.
• Troubleshoot and resolve process-related issues, ensuring minimal disruption to production.
• Author process development reports, validation protocols, and batch records.
• Collaborate with R&D, Quality Assurance, and Manufacturing departments to ensure seamless integration of new processes.
• Stay abreast of new manufacturing technologies and innovative approaches in the pharmaceutical industry.
• Mentor junior engineers and provide technical guidance on process development projects.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 7 years of experience in pharmaceutical process development and scale-up.
• Demonstrated expertise in solid dosage forms and/or sterile drug product manufacturing.
• Proficiency in process modeling, simulation, and statistical analysis software.
• Strong understanding of GMP, FDA/EMA regulations, and validation principles.
• Experience with process validation, IQ/OQ/PQ, and technology transfer.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong project management and leadership abilities.
• Effective communication and interpersonal skills, with the ability to collaborate effectively.
• Experience with automation and advanced manufacturing technologies is desirable.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package including medical insurance, a retirement savings plan, and performance incentives.
• The hybrid work model provides flexibility and work-life balance.
• Generous paid time off, including annual leave and sick leave, is provided.
• Opportunities for continued professional development, including advanced training and conference attendance, are available.
• Employees benefit from a supportive work environment focused on innovation and career growth.
• Life insurance and disability coverage are also part of the package.