6 Facility Management Stellen in Le Locle gefunden

The Team Leader Facility is responsible for the management, improvement, and new implementation of Ichnos’ facilities including equipment (HVAC, gas networks, LN2 storage, cleanrooms, cold rooms, water loop, autoclave, UPS, etc), and coordinating and executing validation activities related to biopharmaceutical facilities, utilities, equipment and associated systems (e.g. HVAC, automation). This role closely interacts with Manufacturing Operation, Quality Assurance.

Project Management:

• Coordinate and prioritize a wide range of projects planning and execution, developing project charters, work breakdown structures, and resource-loaded schedules
• Manage project scope from initiation, planning, execution, monitoring, and close-out.
• Leverage resources to compile cost and schedule estimates for projects
• Oversee the construction and renovation of buildings
• Articulate project requirements to multiple stakeholders both on and off site
• Manage relationships with contractors
• Serve as the point of contact for stakeholders keeping documented progress and reports of all projects
• Report on project performance and status
• Control space allocation and maintain facility project budgets
• Identify risks and develop mitigation strategies to ensure smooth project execution and completion to safety, schedule, budget, and quality
• Identify issues and respond to emergencies
• Play a leading role in the selection of architects, consultants, and engineers to undertake various projects
• Coordinating all required resources to accomplish multiple projects for the site providing prioritization of work
• Participate in developing and enforcing project guidelines for project

• Maintenance and Compliance Activities:
• Ensure that all buildings meet all relevant federal, state, and local building codes
• Ensure commissioning is executed and all final documentation needs are delivered on time
• General management of site utility installations (HVAC, gas networks, LN2 storage, cleanrooms, cold rooms, water loop, autoclave, UPS, etc)
• General management of Master Equipment List for research, development and production equipment including responsibility for routine, exceptional maintenance and requalification
• Optimization and implementation of engineering procedures based on facility needs whilst respecting cGMP (current Good Manufacturing Practices)/cGEP (current Good Engineering Practices) guidelines
• Identify opportunities for process optimization, cost reduction, and efficiency improvements within the maintenance and qualification processes.
• Management of the facility monitoring system for the entire site
• Participate in on-call alarm system management with occasional onsite presence required outside of regular working hours

• Qualification and Documentation:
• Prepare, review and approve SOPs, validation deviations, change control, validation summary reports and associated documentation
• Coordinate validation activities with internal departments, external contractors and suppliers.
• Prepare and deliver cross-functional training in validation methodologies, protocols and related procedures to facilitate validation activities
• Investigate deviations/non-conformances to determine potential impact on product quality, validation status and associated compliance requirements
• Participate in internal and external audits, providing necessary documentation and support to demonstrate compliance with regulatory standards.

• Leadership and Team Management:
• Lead, motivate, and supervise a team of maintenance and qualification technicians.
• Foster a culture of excellence, collaboration, and continuous improvement within the team.
• Provide guidance, training, and support to team members to ensure their professional development and adherence to cGMP standards.