About the Role
The Manufacturing Engineer will play a crucial part in our team at Astellas, working towards making a positive impact on society through innovative manufacturing processes.
This role offers the opportunity to develop your skills and make a meaningful difference in the biologics manufacturing industry.
Key Responsibilities
* Provide technical support and troubleshooting for daily operations, ensuring compliance with regulatory standards and Good Manufacturing Practices (GMP).
* Develop and implement effective guides and procedures for equipment operation, maintenance, and troubleshooting.
* Optimize equipment design principles and provide technical training and associated documentation.
* Collaborate with Validation Engineers to develop and execute validation protocols.
* Analyze data to ensure manufacturing readiness and contribute to lean manufacturing initiatives to optimize efficiency.
* Implement corrective actions to address deviations and improve product quality.
Requirements
* Bachelor's degree in engineering or related field or equivalent experience.
* Industry experience in Biologics/Pharmaceutical manufacturing or other relevant GMP environment.
* Strong understanding of biologics drug substance manufacturing processes, including aseptic filling and lyophilization.
* Excellent communication and collaboration skills, with the ability to work effectively in a fast-paced team environment.
Preferred Qualifications
* Direct experience in drug manufacturing.
* Experience with Lean Manufacturing techniques, statistical analysis, and data science techniques.
Astellas Culture
Astellas is a company that values innovation, teamwork, and patient-centricity. Our open and progressive culture fosters a supportive and inclusive work environment, where every employee has the opportunity to make a meaningful contribution.
We are an equal opportunity employer and welcome applications from diverse candidates.