About This Job
As a Graduate Operations Engineer, you will be responsible for supporting the troubleshooting of equipment used in biologics manufacturing, ensuring compliance with regulatory standards (e.g., FDA, EMA) and Good Manufacturing Practices (GMP), collaborating with Validation Engineers to develop and execute validation protocols, performing data analysis to ensure manufacturing and test readiness, and identifying areas for process improvement and implementing solutions. You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities for this role
1. Department Operation:
o Contribute to and help develop operational / maintenance procedures to achieve and maintain best practice and regulatory compliance.
o Provide support to monitor and analyse equipment performance and initiate actions to avoid possible problems and maximise equipment reliability, robustness and availability.
2. Projects Support:
o Support of Change Control and Commissioning/Qualification activities.
o Support Continuous Improvement through Kaizen, Lean/Six Sigma and Problem-solving methodologies.
3. Reporting:
o Report regularly to the Operations Lead.
o Feedback performance of the equipment, potential problems quickly and accurately, e.g., resources, technical issues, etc.
Essential Knowledge & Experience
* Strong understanding of aseptic manufacturing techniques.
* Familiarity with the ISPE baseline Guide for Commissioning and Qualification.
* Solid understanding of pharmaceutical quality management systems.
* Experience with various QMS tools, such as TrackWise, Valgenesis, and Vault.
* Thorough knowledge and understanding of regional Good Manufacturing Practices for pharmaceutical products.
* Commitment to continuous learning and improvement within the pharmaceutical manufacturing environment.
Education/Qualifications
* Bachelor’s degree in engineering or relevant science discipline or relevant.
Additional Information
* Type of role: full-time permanent.
* Location: Irish office (Tralee plant in County Kerry).
* This position is field-based in Tralee plant / Ireland. Candidates must be located within a commutable distance of the office.
What We Offer
* A challenging and diversified job in an international setting.
* Opportunity and support for continuous development.
* Inspiring work climate.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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