Pharmaceutical Process Engineer
This role involves providing technical leadership and direction for the manufacturing department across various areas including formulation, aseptic filling process, isolator technology, and representation at regulatory audits. Our goal is to ensure the highest quality of pharmaceutical products while adhering to cGMP standards.
Key Responsibilities:
- Owning manufacturing equipment, process knowledge, and technology on-site
- Sourcing and procuring process equipment with technical oversight
- Providing technical support for manufacturing processes and equipment, collaborating with technical teams to ensure standardization and best practices
- Designing and implementing technical studies and programs for investigations and product improvements
- Developing knowledge of new pharmaceutical manufacturing processes aligned with business goals
- Managing continuous improvement projects and collaborating with leadership to implement initiatives
- Driving process improvements for performance enhancement and cost reduction
Requirements:
- A relevant third-level qualification in science, engineering, or a technical discipline; a Master's or PhD in engineering, chemical, or process engineering is advantageous
- At least 3 years' experience in pharmaceutical process engineering, including batch processing, technical transfers, scale-up, commissioning, and validation in a cGMP environment
- Proven project management skills, capable of delivering projects on time, within budget, and to quality standards
- Experience in lyophilization and sterilization operations is preferred