About the Role
Our client, a leading pharmaceutical manufacturer, is seeking a skilled Pharmaceutical Process Engineer to join their technical operations team in Randburg . This role is crucial for optimizing and troubleshooting manufacturing processes to ensure efficiency, quality, and compliance within pharmaceutical production. The ideal candidate will have a strong engineering background, combined with a thorough understanding of pharmaceutical manufacturing principles and GMP regulations. You will be responsible for process design, validation, continuous improvement, and supporting the scale-up of new products. This is an excellent opportunity to apply your engineering expertise in a highly regulated and impactful industry. We are looking for a proactive problem-solver who can drive operational excellence and contribute to the successful production of vital medicines.
Key Responsibilities
- Design, develop, and optimize pharmaceutical manufacturing processes for solid dosage forms, sterile products, or other relevant product types.
- Conduct process validation activities, including IQ, OQ, and PQ, in accordance with regulatory requirements.
- Troubleshoot manufacturing process issues, identify root causes, and implement effective corrective and preventive actions (CAPAs).
- Support the scale-up of processes from laboratory to pilot plant and commercial manufacturing.
- Develop and maintain process documentation, including SOPs, batch records, and engineering drawings.
- Monitor process performance using key metrics and implement continuous improvement initiatives to enhance efficiency, yield, and quality.
- Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless technology transfer and successful product launches.
- Evaluate and recommend new equipment and technologies to improve manufacturing capabilities.
- Ensure all process activities comply with GMP, safety, and environmental regulations.
- Train and mentor junior engineers and technicians on process engineering principles and best practices.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- Minimum of 5 years of experience as a Process Engineer in the pharmaceutical or a highly regulated manufacturing industry.
- Strong understanding of pharmaceutical manufacturing processes, equipment, and GMP requirements.
- Proven experience in process validation, optimization, and troubleshooting.
- Proficiency in process simulation software and data analysis tools is a plus.
- Excellent problem-solving skills, analytical thinking, and attention to detail.
- Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
- Familiarity with Lean Manufacturing or Six Sigma principles is desirable.
- Ability to manage multiple projects and meet project deadlines.
- Knowledge of specific pharmaceutical dosage forms (e.g., tablets, capsules, sterile injectables) is an advantage.
Benefits
Our client offers a competitive salary, comprehensive health insurance, retirement benefits, and opportunities for professional development and advancement. This role is based in Randburg , providing a stimulating work environment within a key industrial hub. You will be part of a dedicated team focused on innovation and quality in pharmaceutical manufacturing. Our client is committed to employee growth and provides ongoing training to keep pace with industry advancements.
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Pharmaceutical Process Engineer - Randburg in Southampton employer: Placements24
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