Description
Clean utilities EngineerJob Description:
The Responsible Engineering (RE) Clean Utilities own and provides engineering technical support for all Clean/GMP Utilities for the Solothurn campus. The campus consists of a Central Utilities Building, Warehouse, BMC's, and related supporting buildings and equipments. 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 equipments in terms of: Design of new equipments 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.
Main Accountabilities
- Analyzes Customers, Regulation and Biogen 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 equipements by providing faisibility study, URS, Project plan, budget, project management, costs control, commissioning and documentation.
- Provide utilities equipments 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.
Qualifications
- 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
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.