Pharmaceutical Engineer
7 days ago
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.
Tell employers what skills you have
FDA
Quality Control
Regulatory Compliance
Regulatory Affairs
Software Project Management
Manufacturing Processes
Process Simulation
GMP
Formulation
Drug Delivery
Research and Development
Medical Affairs
Facility Design
Process Optimization
Pharmaceuticals
Teamwork Skills
Regulatory Submissions
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