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Title
Text copied to clipboard!Pharmaceutical Engineer
Description
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We are looking for a dedicated and experienced Pharmaceutical Engineer to join our dynamic team. The Pharmaceutical Engineer will play a crucial role in the design, development, and optimization of pharmaceutical manufacturing processes, ensuring compliance with regulatory standards and enhancing production efficiency. The ideal candidate will possess a strong background in chemical engineering, pharmaceutical sciences, or related fields, and demonstrate a deep understanding of pharmaceutical manufacturing technologies, quality control, and regulatory requirements.
In this role, you will collaborate closely with cross-functional teams, including research and development, quality assurance, regulatory affairs, and production departments, to ensure seamless integration of new processes and technologies. You will be responsible for identifying opportunities for process improvements, conducting feasibility studies, and implementing innovative solutions to enhance product quality, reduce costs, and increase manufacturing efficiency.
Your responsibilities will include developing and validating manufacturing processes, preparing detailed documentation, and ensuring compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant industry standards. You will also be involved in troubleshooting production issues, conducting root cause analyses, and recommending corrective actions to prevent recurrence.
Additionally, you will participate in the selection, installation, and qualification of new equipment and technologies, ensuring they meet the required specifications and regulatory standards. You will provide technical support and training to production personnel, ensuring they understand and adhere to established processes and procedures.
The successful candidate will have excellent analytical and problem-solving skills, strong attention to detail, and the ability to manage multiple projects simultaneously. You must possess effective communication and interpersonal skills, enabling you to collaborate effectively with colleagues at all levels of the organization.
We offer a stimulating work environment, opportunities for professional growth, and the chance to contribute significantly to the advancement of pharmaceutical manufacturing processes. If you are passionate about pharmaceutical engineering and committed to excellence, we encourage you to apply and become a valuable member of our innovative team.
Responsibilities
Text copied to clipboard!- Design and optimize pharmaceutical manufacturing processes to ensure efficiency and compliance.
- Develop and validate new manufacturing processes and technologies.
- Prepare detailed documentation and ensure compliance with GMP and regulatory standards.
- Collaborate with cross-functional teams to integrate new processes and technologies.
- Troubleshoot production issues and conduct root cause analyses.
- Recommend and implement corrective actions to prevent recurrence of production issues.
- Participate in the selection, installation, and qualification of new equipment.
- Provide technical support and training to production personnel.
- Conduct feasibility studies and identify opportunities for process improvements.
- Ensure adherence to FDA regulations and other relevant industry standards.
Requirements
Text copied to clipboard!- Bachelor's degree or higher in Chemical Engineering, Pharmaceutical Sciences, or related field.
- Minimum of 3-5 years of experience in pharmaceutical manufacturing or process engineering.
- Strong knowledge of GMP, FDA regulations, and pharmaceutical industry standards.
- Experience with process validation, equipment qualification, and technology transfer.
- Excellent analytical, problem-solving, and troubleshooting skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Strong communication and interpersonal skills.
- Proficiency in relevant software and tools used in pharmaceutical engineering.
- Detail-oriented with a commitment to quality and compliance.
- Ability to work effectively both independently and as part of a team.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with pharmaceutical process validation?
- How do you ensure compliance with GMP and FDA regulations in your work?
- What steps do you take when troubleshooting a production issue?
- Can you provide an example of a process improvement you implemented?
- How do you manage multiple projects and prioritize tasks effectively?
- What experience do you have with equipment qualification and technology transfer?
