Clean Utilities S.M.E.
Category: Project Management & Agile
Location: Dublin, Leinster, IE
It's not every day that you get to help set up an entire production site from scratch? Would you like to be part of a once in a lifetime opportunity to contribute to the health of millions?
Then this may be your chance!
Join our Team based in West Dublin as the Clean Utilities subject Matter expert for the Fill & Finish (FF) Expansion Ireland Project!
Position Purpose: The purpose of this position is to lead design, installation & commissioning/qualification of new clean utilities systems for the FF Ireland facility.
Responsibilities
- Create & maintain system specifications for clean utilities.
- Support all design, installation, commissioning, qualification, training activities for clean utilities.
- Provide additional technical support to project team as required.
- Adhere to all quality & environmental regulations within area of responsibility.
- Support technical development of facilities technicians after handover to LOB.
- Continuous process improvement using cLEAN® concepts.
- Maintain & establish standards for procedures & maintenance plans.
- All safety & environmental requirements in the performance of duties.
Qualifications
- Minimum of eight to fifteen (8-15+) years engineering experience in a manufacturing facility.
- Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA).
- Thorough knowledge of clean utilities systems to include: WFI, pure water, chilled water, clean steam, process air, electrical. A strong demonstrated ownership & innovation of clean utility systems required
- Knowledgeable in black utilities systems to include: chilled water, plant steam, compressed air, vacuum, wastewater, cryogenic storage, and HVAC.
- Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems.
- Thorough understanding of technical documents such as URS, SAT, FAT.
- Thorough understanding of complicated product documentation & standard operating procedures with attention to high-level concepts.
- Computer literacy with associated required systems.
- Demonstrated knowledge & proficiency in change control processes & familiarity with validation & commissioning methodology & processes.
- Proven expertise in planning/organization/execution of project & maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams.
About the department
You will be joining Fill & Finish Expansions. The area is anchored in Product Supply, Quality & IT, which globally employ approximately 20,000 of Novo Nordisk’s 50,000 employees.
Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all major fill & finish expansion projects across PSQIT to serve the needs of millions of patients.
We do it by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, designing facilities we will still be proud of 20 years from now.
Fill & Finish Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence, without fixating on perfection. We never shy away from opportunities to develop we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care
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