Job Description
We are seeking an experienced Equipment Specialist to join our team in a Client site in Cork. The successful candidate will be responsible for managing project deliverables and equipment qualification through technology transfer and commercialization in a new manufacturing facility.
Key Responsibilities:
1. Develop a deep understanding of the Manufacturing and Laboratory equipment being purchased and installed as part of the project.
2. Plan, coordinate and execute onsite validation activities - Installation Qualification (IQ) and Operational Qualification (OQ).
3. Work closely with cross functional teams in monitoring project performance.
4. Provide weekly status updates on progress, highlight issues as well as suggesting solutions.
5. Support all company safety and quality programs and initiatives.
6. Ensure compliance with cGMP and safety rules on new and existing equipment.
7. Support production equipment transfer, taking a hands-on lead role in activities required to achieve commercialization.
8. Provide engineering inputs to the design / URSs for process equipment.
9. Support the training of engineers and production personnel.
10. Project manage / coordinate key projects and the project workstream within the areas of assigned responsibility.
11. Support the continuous improvement strategy in conjunction with the Manufacturing, Quality and Engineering functions in the area.
12. Identify, support or direct the execution of improvement efforts to reduce waste, increase yields and improve product quality in the manufacturing area.
13. Identify and develop risk-based approach to change management in conjunction with validation and QA groups.
14. Support the more junior engineers in the development of URS documents, interactions with key equipment vendors, and execution of effective commissioning and qualification protocols.
15. Ensure that accurate and representative equipment performance data is generated, gathered, analysed and trended.
16. Deliver regular reporting of equipment performance and provide technical support to sustaining manufacture operations.
17. Apply and lead DMAIC - Six Sigma approaches to solve issues and reduce variation in all manufacturing areas.