Job Summary:
We are seeking a highly motivated and skilled Pharmaceutical Engineer to join our team. The successful candidate will play a pivotal role in the design, development, and manufacturing of pharmaceutical products. This position requires a deep understanding of pharmaceutical processes, regulatory compliance, and quality assurance. If you are a dedicated professional with a passion for ensuring the safety and efficacy of pharmaceutical products, we encourage you to apply.
Key Responsibilities:
- Drug Formulation: Collaborate with cross-functional teams to develop drug formulations, select suitable excipients, and optimize drug delivery systems.
- Process Development: Design, scale-up, and optimize pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance with regulatory standards.
- Quality Control: Develop and implement quality control methods and protocols to monitor and ensure product quality throughout the manufacturing process.
- Regulatory Compliance: Stay up-to-date with pharmaceutical regulations (e.g., FDA, EMA) and ensure that all manufacturing processes and products adhere to relevant standards.
- GMP Adherence: Maintain adherence to Good Manufacturing Practices (GMP) and develop and update standard operating procedures (SOPs) as needed.
- Validation: Develop and execute validation protocols for manufacturing processes, equipment, and facilities to ensure consistent product quality.
- Research and Development: Participate in R&D activities, conduct experiments, analyze data, and contribute to the development of new drug compounds or dosage forms.
- Equipment and Facility Management: Select, install, and maintain pharmaceutical manufacturing equipment and facilities to ensure compliance with regulatory requirements.
- Documentation: Maintain accurate and comprehensive documentation of all processes, experiments, and validations for regulatory purposes.
- Collaboration: Work collaboratively with multidisciplinary teams, including chemists, pharmacists, regulatory affairs specialists, and quality control professionals.
- Continuous Improvement: Identify opportunities for process optimization, cost reduction, and quality enhancement, and implement improvements accordingly.
Qualifications:
- Bachelor's or higher degree in pharmaceutical engineering or any engineering related field.
- 5 years + of experience in pharmaceutical manufacturing or process development.
- Strong knowledge of pharmaceutical regulations, including GMP and FDA guidelines.
- Proficiency in data analysis and statistical tools.
- Excellent communication and teamwork skills.
- Detail-oriented with a commitment to quality and safety.
- Problem-solving and critical thinking abilities.
Preferred Qualifications:
- Bachelor's Degree in pharmaceutical engineering or any engineering related field.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Knowledge of pharmaceutical equipment and facility design.
- Familiarity with process simulation software.
- Project management skills.
