Wash & Sterilisation Professional to new Insulin filling facility - Denmark
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- The number of people with diabetes is increasing dramatically.
- Therefore,our company has initiated an exciting project to build a new insulin filling facility.
- The project will have a high degree of complexity with lots of cross organisational and global cooperation.
- To succeed with this ambitious project we need people with a pioneer spirit who like to build something new, that have high engagement and that thrive in a constant changing environment.
About the department
- The production department in the project is responsible for purchasing, implementing, validating and manning the production equipment and processes for the new facility.
- The production department is divided into four areas Filling, Inspection, Formulation and Wash & Sterilization.
- You will be part of the Wash & Sterilization area that consist of two teams, the team you will join is a dedicated project team consisting of 13 colleagues.
- You will be a Wash & Sterilization Professional and report to the Associate Manager for the Wash & Sterilization team.
- The team has the responsibility for implementation of equipment such as utensil washers, autoclaves, rinsing basin, ultrasonic bath.
- The implementation of equipment includes purchasing, installation, validation, ramp up and regulatory approvals.
- The team works closely together with the vendors of the equipment, the engineering partner and the other teams in the project.
- In addition the team is responsible for creating standards, and the processes that will secure our future procedures at the new facility.
- When all the processes are documented and implemented, you and the team will be responsible for maintaining the standards on a high level and making sure our equipment is working as efficiently as possible to secure a stable operation.
- After a period of introduction and training it will be your job to contribute to the establishment of the sterilization strategy for Wash & Sterilization equipment in the project.
- Plan and drive Cycle Development together with Process Qualification for our Autoclaves.
- Once in operation you will secure that the equipment within your area of responsibility is fully functional at all times and is ready for inspections and audits.
- To this end, you make sure that it operates in full compliance with GMP standards.
- You will handle the documentation, including preparation of specification requirements for the users, reports on deviations and handling of change requests.
- You will also contribute in keeping the sterilization strategy updated, present during inspections; make trouble shooting during deviations, train and advice employees in Wash & Sterilization on sterilization matters
- It is important that you are able to network, collaborate and work at a high professional level, both internally and externally.
- It is necessary to have a sense for details and also ensure an efficient and timely project execution.
- Optimally you have 5-10 years of experience with practical and theoretical knowledge within sterilization in Aseptic Pharmaceutical Production, special focus on Wash & Sterilization equipment. You have project experience and hold a MSc or PhD within microbiology, biotechnology, chemistry or similar.
Working with us:
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.