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Responsible Engineer Clean Utilities - Switzerland
Posted on : 10 July 2017
- The Responsible Engineering (RE) Clean Utilities own and provides engineering technical support for all Clean/GMP Utilities for the campus.
- The campus consists of a Central Utilities Building, Warehouse, BMC’s, and related supporting buildings and equipment.
- This function will plan and co-ordinate all Clean/GMP utilities engineering activities to meet the campus needs in terms of Clean/GMP utilities capacities and reliability in full compliance with Safety, Quality, and Compliance.
- He will provide the technical expertise to the campus Clean/GMP Utilities operation team and equipment in terms of: Design of new equipment and changes, Reliability methodology, Investigation of technical issues, Establish SOP, Maintenance plans and Technical training for operators and technicians.
- This position will also be instrumental in building the required cGMP procedures for the Clean/GMP Utilities and align them with global procedures and guidelines.
- Analyzes Customers, Regulation and company policies/SOP expectation for Clean/GMP Utilities and identify any gaps with our actual systems. Evaluate the risks correlated with the gaps and propose preventive/corrective actions.
- Troubleshoots equipment’s function failure and performs rootcause investigations and analysis.
- Apply the concept of Reliability Engineering, monitors and benchmarks equipment operability and performance, creates metrics.
- Deliver projects for new and modified utilities equipment by providing faisibility study, URS, Project plan, budget, project management, costs control, commissioning and documentation.
- Provide utilities equipment identification, criticality, maintenance assessment, CMMS data, hierarchie, maintenance strategie, Spare parts stocks levels and maintenance plans to the Planning & Scheduling team. Responsible for accurate content of equipment master data, EPL and BOM’s in CMMS. Promote the continuous improvement of the utilities preventive maintenance program effectiveness.
- Establish & maintains procedures and technical training related to the Utilities Operations and Maintenance Program that ensures compliance to EHS and cGMP’s.
- Creates and maintains systems that promote safety and comply with all safety procedures and regulations.
- Ensures all safety incidents are properly investigated and corrective / preventive actions are implemented.
- Participates in cross site maintenance benchmarking and improvement meetings, communicates across departmental lines.
- Excellent technical knowledge of Clean/GMP utility systems : (RO Water, WFI, Clean steam, Process compressed air, Gas) and Electricity, HVAC, BMS systems
- - Excellent understanding of Utilities / Reliability Maintenance
- - Similar experience within industrial Utilities environment and within GMP regulated for Clean Utilities.
- - Good understanding of cGMP operations
- - Demonstrate good verbal and written communication
- - Demonstrate good interpersonal skills including the ability to resolve problems with poise, tact and diplomacy
- - Good leadership / Team player / Accountability
- - Good knowledge of Reliability methodology
Education | BS/MS Degree in Engineering
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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