The job purpose is to ensure the overall operations and compliance of the clean utilities (purified water, clean steam, and clean gases) with respect of the GMP, Novartis QM and HSE requirements.
Ensure the business continuity of the clean utilities installations and deliver a high quality support and expertise to the internal customers and technical project teams.
- Respect all GMP standards.
- GMP knowledge and experience to support the requirements expected by Swissmedic, European Union agencies and other regulatory bodies to assure that our products meet all GMP requirements together with our operations and documentation system.
- As system owner, manage and lead Deviations/CAPA/Change Control with quality and respect of the due dates.
- Lead investigation for the deviation, and use Six sigma tools such as root cause analysis methods to establish root causes to any issues that may arise and implement robust corrective measures.
- Ensure that all engineering drawings and documentation are maintained in compliance with relevant standards.
- Is the clean utilities representative for the internal and external audits.
- Ensure efficient and appropriate maintenance of the clean utilities.
- Respect and apply the Novartis HSE requirements.
- Ensure that all operations including preventive and corrective maintenance activities are managed in accordance to HSE rules.
- Use of permit to work system to control engineering activities.
.SUPPORT TO PROJECT ACTIVITIES:
- Provide technical support to the project team in charge of the implementation of all clean utilities installations.
- Lead commissioning activities and the qualification of all clean utilities installations.
- Support the startup of all clean utilities with the project team.
- Train and develop the utilities technician competencies.
- Develop the maintenance program for the new clean utilities system in accordance with GMP and Novartis QM.
.CLEAN UTILITIES OPERATIONS:
- Ensure the overall operations and compliance of the clean utilities, with respect of the GMP, Novartis QM and HSE requirements.
- Ensure that maintenance and calibration is carried out in an effective way with the respect of the GMP.
- Ensure clean utilities production capacity.
- Ensure daily, weekly and monthly activities are properly executed by the utilities technicians.
- Prepare and organize maintenance during planned and annual shutdown with the utilities team, internal employees and service providers (planning, offer, contract, periodic review, purchased order).
- Develop a reliability program for utilities and critical building systems.
- Develop maintenance contracts with subcontractors.
- Implement a high performance and continuous improvement culture driven by key performance metrics.
- Propose and manage technical change on the clean utilities system.
- Generate report and analyze key utility metrics.
- Implement and develop the business continuity of the clean utilities.
- Could have to support the activities standby duty 24h/7 in case of urgency.
- Master of science degree in engineering, process, mechanical or clean utilities preferred.
- French and English fluent.
- Technical knowledge of clean utilities is required: purified water, clean steam and clean gases.
- Technical knowledge of maintenance, process and engineering.
- Experience with GMP regulated processes.
- A minimum of 5 years in a similar position.