Job Overview
A Manufacturing Engineer will be responsible for equipment installation, maintenance and troubleshooting in a biologics manufacturing environment.
* Provide daily technical support and collaborate with Operations and Engineering Teams to optimize equipment design and performance.
* Develop 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.
* Collaborate with Validation Engineers to create and execute validation protocols ensuring manufacturing and test readiness.
* Contribute to lean manufacturing initiatives, process improvements and cross-functional alignment between product design, Quality, Operations and Engineering teams.
Key Responsibilities:
* Expertise in Aseptic Filling and Lyophilization processes, leading meetings to optimize machine operations and support product development goals.
* Essential Knowledge & Experience: Extensive experience in Biologics/Pharmaceutical manufacturing or a relevant GMP environment, with a focus on aseptic filling and lyophilization.
* Flexible to support GMP Operations with a dynamic work schedule to meet business needs.
* Education: Minimum bachelor's degree in engineering or related field or equivalent experience.
Benefits and Work Environment:
* Dynamic work schedule to meet business needs.
* Opportunity to contribute to lean manufacturing initiatives and process improvements.
* Cross-functional alignment between product design, Quality, Operations and Engineering teams.
Requirements:
* 20% travel required for domestic and international assignments.
* This is a full-time position requiring 100% onsite presence.