About the Role
Our client, a distinguished leader in the pharmaceutical manufacturing sector, is seeking a skilled Process Development Engineer to join their operations in Klerksdorp, North West . This role is pivotal in optimizing and scaling up pharmaceutical manufacturing processes to ensure efficiency, quality, and cost-effectiveness. You will be responsible for the development, validation, and continuous improvement of manufacturing processes for various pharmaceutical products. The ideal candidate possesses a strong engineering background, hands‑on experience with manufacturing equipment, and a deep understanding of GMP principles. Join a forward-thinking company dedicated to producing high-quality pharmaceuticals and contributing to improved patient outcomes. This is an excellent opportunity to make a significant impact in a dynamic manufacturing environment in Klerksdorp.
Key Responsibilities
- Develop, optimize, and scale-up pharmaceutical manufacturing processes, including granulation, blending, tablet compression, coating, and sterile filling.
- Design and execute experiments to define process parameters and operating ranges.
- Perform process validation activities, including IQ, OQ, and PQ protocols.
- Troubleshoot manufacturing issues and implement effective solutions to minimize downtime and improve yield.
- Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless technology transfer and process implementation.
- Author process development reports, validation reports, and relevant sections of regulatory filings.
- Ensure all process development activities comply with GMP, safety, and environmental regulations.
- Identify opportunities for process improvement and cost reduction initiatives.
- Evaluate and recommend new manufacturing technologies and equipment.
- Maintain accurate and detailed records of all process development activities.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field.
- A Master's degree is a plus.
- Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
- Proven experience with various pharmaceutical manufacturing operations (e.g., solid dosage, sterile manufacturing).
- Strong understanding of GMP, validation principles (IQ/OQ/PQ), and regulatory requirements.
- Hands‑on experience with process equipment and instrumentation.
- Excellent problem‑solving, analytical, and critical thinking skills.
- Proficiency in process simulation and modeling software is desirable.
- Strong project management and organizational skills.
- Effective communication and interpersonal skills, with the ability to work collaboratively across departments.
- Detail‑oriented with a commitment to quality and safety.
- Experience with statistical process control (SPC) is an advantage.
- Familiarity with lean manufacturing principles.
Benefits
- Our client provides a competitive salary package, commensurate with experience, along with opportunities for performance‑based bonuses.
- Comprehensive medical coverage, including hospital plans and specialist consultations, is offered.
- A generous annual leave policy and paid sick leave contribute to employee well‑being.
- Professional development opportunities, such as specialized training courses and industry conferences, are encouraged and supported.
- Employees are enrolled in a retirement savings fund with employer contributions.
- The role is based in Klerksdorp, offering a chance to work in a modern manufacturing facility with advanced technology and a supportive team culture.
- Our client is committed to fostering career growth and offers clear advancement opportunities within the pharmaceutical manufacturing sector.