Team Leader Facilities

RESPONSIBILITIES:

1. 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

2. 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

3. 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.

4. 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
  • Knowledge and application of key aspects of relevant cGMP/cGEP
  • 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