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Sébastien Le Gouil

Consultant – FRANCE

Experience

Experienced Engineering and Technical Director with over 20 years
of experience in the pharmaceutical industry. Proven track record
in project management, technical operations, and maintenance.
Skilled in leading cross-functional teams to achieve project goals and optimize production processes.
Expert in sterile products and packaging. Also experienced in liquids, pastes, and solid forms, including high-potency API.
Most projects managed were in compliance with US GMP regulation rules.

Capabilities

  • Skilled in CapEx management.
  • Fluent in French and English.
  • Strong background in developing and executing projects.
  • Can manage all kinds of pharmaceutical CapEx projects from the project brief to the end of qualification, including the specification of equipment, design of the facility regarding all regulatory and operational requirements, in terms of flows, surfaces, containment, clean rooms, air treatment, and clean utilities.

Focus Areas

  • Project Management
  • Equipment specification and procurement
  • Specification of production areas
  • Organization of technical department activities

What I can do for you

  • Feasibility studies and preliminary design
  • Basic engineering and detailed design
  • Equipment procurement and installation supervision
  • Commissioning and qualification support
  • Process optimization and validation execution
  • Regulatory compliance, CAPA plan

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