Job Description: Pharmaceutical Engineer
Position: Pharmaceutical Engineer
Department: Engineering
Reporting to: Engineering Manager
Job Overview:
We are seeking a highly skilled and dedicated Pharmaceutical Engineer to join our dynamic team. The successful candidate will be responsible for designing, developing, and implementing pharmaceutical manufacturing processes and equipment. Their primary focus will be on ensuring compliance with regulatory standards, optimizing production efficiency, and maintaining product quality within the pharmaceutical industry.
Key Responsibilities:
- Collaborate with cross-functional teams to develop and optimize pharmaceutical manufacturing processes and equipment, ensuring compliance with all applicable regulations and standards.
- Design, evaluate, and troubleshoot pharmaceutical manufacturing processes, including formulation, mixing, granulation, drying, and packaging.
- Conduct feasibility studies and process simulations to identify potential areas for improvement and implement innovative solutions.
- Perform risk assessments and develop strategies to mitigate potential hazards and ensure product safety.
- Develop and maintain detailed technical documentation, including process specifications, validation protocols, and standard operating procedures (SOPs).
- Identify and implement process optimization initiatives to improve productivity, reduce costs, and enhance product quality.
- Collaborate with quality assurance and regulatory affairs teams to ensure compliance with cGMP (current Good Manufacturing Practices) guidelines and regulatory requirements.
- Conduct root cause analysis and implement corrective and preventive actions to address process deviations and non-conformities.
- Provide technical support and training to production personnel on new processes, equipment, and SOPs.
- Stay updated with the latest industry trends, advancements, and regulatory changes related to pharmaceutical engineering.
Required Skills and Qualifications:
- Bachelor's degree in Chemical Engineering or a related field. Master's degree preferred.
- Proven experience in pharmaceutical manufacturing process development, preferably within a regulated environment.
- Strong knowledge of cGMP guidelines and regulatory requirements.
- Proficient in process design, simulation, and optimization techniques.
- Familiarity with pharmaceutical equipment, such as granulators, dryers, mixers, and packaging machines.
- Excellent problem-solving and analytical skills, with the ability to identify and resolve complex technical issues.
- Detail-oriented with exceptional organizational and project management abilities.
- Strong written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams.
- Ability to work independently and meet project deadlines while maintaining a high level of accuracy and quality.
- Proficient in using relevant software tools and data analysis techniques.
Note: This job description outlines the general nature and level of work performed by individuals assigned to this position. It does not include all possible duties, tasks, and responsibilities that may be required and can be subject to change based on organizational requirements.