Capex Automation Project Manager

at  CONSULTYS

We are looking for a Project Manager with experience in leading CAPEX projects in a GMP environment and having specifically a strong understanding of automation systems.

REQUIRED QUALIFICATIONS:

• Proven understanding of automation systems related to pharmaceutical business
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility. Understanding of GMP requirements related to automation systems, and related principles (data integrity, ERES, compliance to 21-part part 11, …)
• Ideally experience with Trackwise
• 5+ years practical and leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems’ function.
• Understanding of project management principles, project life-cycle phases and stage gate methodology.
• Proficiency in German and English.
• Strong organizational skills
• Excellent teamwork and communication skills.
  Qui sommes nous ?
  Since 2005, the largest laboratories have renewed their trust in us. Specialized in pharmaceuticals, biotechnology and medical devices, we support our clients from R&D to the market launch of their products.
  Human-scale company, belonging to the Vulcain Engineering Group, we are committed to supporting and advancing our employees who are recognized for their technical and scientific expertise. Through our regional subsidiaries, we guarantee each one a geographical stability, without mobility clause on the main basins of activities in France, Belgium, Switzerland, Denmark and Canada.
  At Consultys, we prove that it is possible to combine Human and Performance.
  Much more than concepts, our 3 values “Respect, Recognition and Transparency” guide us and are the foundation of our history, the heart of our group’s success.

Most of Consultys:

• Stable, senior teams that accompany you in taking charge of your position
• Tailor-made training tailored to your career prospects
• The guarantee of working close to you, without geographical mobility

• Leading CAPEX projects having their focus on automation systems, that will be new or existing systems to be upgraded or extended.
• Responsible for project activities required to scope, develop, procure, install, and qualify automation systems used in pharmaceutical manufacturing processes / utilities’ systems
• Moderates and organizes multi-disciplinary teams and activities through project life cycle activities to deliver project scopes to meet global and local strategic requirements.
• Understanding of interfaces between the automation systems and process equipment / utilities systems and interfaces to IT systems / MES.
• Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval.
• Generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for senior site management and Global Steering Committees