von: Gi Life Sciences Basel | Ort: Bern
N: GiLifeSciencesBasel
N: GiLifeSciencesBasel
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.
Tasks and 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
Your profile
- 5+ years practical and leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems’ function
- 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)
- Understanding of project management principles, project life-cycle phases and stage gate methodology
- Ideally experience with Trackwise
- Strong organizational skills
- Excellent teamwork and communication skills
- Proficiency in German and English
General information
- Start date: ideally November 2024
- Duration of employment: initially planned for 12 months
- Place of work: Bern
- Workload: 100 %
Your application
If you are interested in this opportunity, please send your CV in German or English.
N: GiLifeSciencesBasel