CAPEX Project Manager (Automation) (m/w/d)

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.

Skills: CAPEX,MES

Start of project: 01.11.2024

Duration of the project : 12 months

Location: Bern, Schweiz

Responsibilities:

• 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

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.