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* Daily line technical support and troubleshooting with the Operations and Engineering Teams.
* Support implementation of effective guides and procedures for: Equipment Operation, troubleshooting etc.
* Understand and look to optimise equipment design principles.
* Provide technical training and associated documentation.
* Key technical expert in your field and in technical problem-solving practices in general.
* Implement corrective actions to address deviations and improve overall product quality.
* Collaborate with Validation Engineers to develop and execute validation protocols.
* Perform data analysis to ensure manufacturing and test readiness.
* Contribute to lean manufacturing initiatives to optimize efficiency.
* Identify areas for process improvement and implement solutions.
* Work closely with global product design teams, Quality, Operations and Engineering teams to align manufacturing processes with product development goals.
* Become process experts on Aseptic Filling and Lyophilisation.
* Participate and lead cross-functional meetings to optimal machine operation.
Minimum Requirements
* Minimum bachelor’s degree in engineering or related field or equivalent experience.
* Industry experience in Biologics/Pharmaceutical manufacturing or other relevant GMP environment.
* Understanding of biologics drug substance manufacturing processes, with a strong focus on aseptic filling and lyophilization a distinct advantage.
* Excels in a fast-paced team environment and completes assigned work in a timely fashion.
* Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.
* This role is required to support GMP Operations. The work schedule is subject to change to support business operations.
Preferred Knowledge & Experience
* Direct experience in drug manufacturing.
* Experience with Lean Manufacturing techniques, statistical analysis and data science techniques and implementation an advantage.
Additional Information
* 20% travel (domestic and International).
* This is a permanent role.
* Based at manufacturing plant Tralee.
* This role is onsite.
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