Technical Service Supervisor

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. 

RESPONSIBILITIES 

• Management of the facility with regard to preventive and  corrective maintenance, alarm and utilities management, including implementation and management of a GMP Global Maintenance/CMMS System.
• Management of approved service providers to support preventative and corrective maintenance as well as equipment requalification/calibration.
• Management of all  equipment  including installation within the facility.
• Periodic requalification and problem solving of current equipment/processes which will require work under GMP conditions including classified clean rooms.
• Support of the Production and Quality Control (QC) Departments in facilitating their day-to-day operations including investigations and problem-solving involving equipment and the facility.
• Serve as resource for the Building Management (BM System and the Environmental Monitoring System (EMS).
• Responsible for all equipment and its commissioning, including:
  • Uniformity of User Requirement Specifications, equipment ordering, Qualification & Periodic requalification
  • Follow-up with subcontractors and their planning of intervention regarding Production & QC activities.
• Ensure compliance to  Good Manufacturing Practice (GMP) contribute to continuous improvement in Department and facility.
• Contribute to correct and reach Key Performance Indicators (KPI).
• Responsible for safety performance related to maintenance and calibration activities. Lead equipment safety assessments and direct relations with safety advisor.
• Ensure appropriate Standard Operating Procedures (SOPs) are available and meet regulatory and cGMP compliance standards. i.e., overlap with the quality system (Change Control, Derogation, Deviation Management, Corrective and Preventive Actions (CAPA), follow-up, room management, etc.).

SKILLS/QUALIFICATIONS 

• Hands on Leader with Good Communication/Coordination Skills
• IT, system and Technology Oriented.
• Client Oriented.
• Rigorous and diligent.
• Demonstrated Cross-Functional Team Spirit.
• Flexible and Open.

EDUCATION/EXPERIENCE 

• Degree in Engineering, (Bio)Process Engineering, or science degree with relevant experience in the fields of GMP Biotech/Pharma/Cell Therapy.
• Previous experience (2-3 years) in infrastructure for pharmaceutical field is a plus, i.e. technical support/maintenance/validation/clean room.
• Experience in safety is a plus.