Astellas is a company that develops innovative treatments to improve patients' lives.
Job Description
As a Manufacturing Engineer, you will ensure the smooth operation of equipment used in biologics manufacturing while maintaining regulatory standards and Good Manufacturing Practices (GMP).
* Provide daily technical support and collaborate with Operations and Engineering Teams to optimize equipment design and performance.
* Develop and implement guides, procedures, and training to improve equipment operation and troubleshooting.
* Lead technical problem-solving efforts and provide expertise on process improvements, focusing on quality and efficiency.
You will work closely with Validation Engineers to create and execute validation protocols, ensuring manufacturing and test readiness. Additionally, you will contribute to lean manufacturing initiatives, process improvements, and cross-functional alignment between product design, Quality, Operations, and Engineering teams.
Requirements:
* Extensive experience in Biologics/Pharmaceutical manufacturing or a relevant GMP environment, with a focus on aseptic filling and lyophilization.
* Strong interpersonal and collaborative skills, thriving in a fast-paced team environment and contributing to a positive, supportive workplace.
* Flexibility to support GMP Operations with a dynamic work schedule to meet business needs.
This role requires approximately 20% travel, both domestic and international.