Facilities and Engineering Manager
MaSTherCell is a dynamic global cell and gene therapy Contract Development and Manufacturing Organization (CDMO), expanding its world presence with capabilities in the United States. MaSTherCell will be opening a new cell and gene therapy process development and production site in the Houston Metropolitan Area in the very near future. It will continue to combine academic and industry excellence to provide unparalleled quality manufacturing services to the cell therapy community. MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies for critical diseases. MaSTherCell operates globally with additional operations in Europe, Israel, and Korea.
- Provide leadership for the Facilities and Engineering Team to ensure effective contribution and performance, including out of normal hours support to the business operations.
- Management of the facility preventive and corrective maintenance program, including implementation and management of a Good Manufacturing Practice (GMP) Computerized Maintenance Management System (CMMS).
- Management of approved service providers to support preventative and corrective maintenance as well as equipment requalification/calibration.
- Management of new equipment installation and qualification within the facility.
- Custodian of the Alarm Management System infra-structure and response to GMP and non-GMP infra-structure related alarms.
- Periodic requalification of current equipment and systems which will require work under GMP conditions including entry into classified clean rooms.
- Support of the Manufacturing and Quality Control (QC) Departments in facilitating their day-to-day operations including investigations and problem-solving involving equipment and the facility support infra-structure.
- Serve as owner and expert resource for the Building Management System (BMS) and the Environmental Monitoring System (EMS). Review of system generated data to ensure compliant performance of systems.
- Ensure equipment and systems under department responsibility are compliant to current Good Manufacturing Practice (cGMP).
- Develop and support relevant Key Performance Indicators (KPIs) to demonstrate performance and provide focus for Continuous Improvement.
- Responsible for safety performance related to facility maintenance and calibration activities. Lead equipment safety assessments and direct relations with safety advisor when appropriate.
- Ensure appropriate Standard Operating Procedures (SOPs) are available and meet regulatory and cGMP compliance standards. i.e. are synchronized with the Quality Management Systems (QMS).
- Hands on Leader with Good Communication/Coordination Skills.
- System, machine and Technology Oriented.
- Service Oriented.
- Rigorous and diligent.
- Demonstrated Cross-Functional Team Spirit.
- Flexible and Open.
- Degree in Engineering, (Bio)Process Engineering, or science degree with relevant experience in the fields of GMP Biotech/Pharma/Cell Therapy.
- Two plus (2+) years previous experience in infrastructure for pharmaceutical field is a plus, i.e. technical support/maintenance/validation/clean room.
- Experience in the management of safety is an advantage.