Team Leader Facilities
Vor 3 Tagen
**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
- 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 projects
- **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.
**EDUCATION AND DESIRED EXPERIENCE**:
- MS' degree or equivalent with at least three years of industrial experience in pharmaceutical area, preferably in a GMP production environment
- Good knowledge of equipment and processes commonly used
during biologics production
- Good knowledge of softwares for Project management, CMMS, FMS, automatisation
- Some financial knowledge and experience with State authorities, lessors or utilities companies
- Strong sense of discipline, exceptional organization skills, excellent team orientation and hands-on approach to work
- Ability to work independently with proven experience in problem analysis/solving, anticipation and proactivity.
- Fluent in French and strong communication skills in spoken and written English
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