Lead Engineer - Commissioning and Qualification (m/f/d), Berlin

Bayer is an international group whose core businesses lie in the healthcare and agriculture sectors. At the intersection of chemistry and biology, Bayer helps to improve quality of life by offering products and services in human and plant health.

Missions

• Plan and coordinate Commissioning and Qualification (C&Q) activities in Pharma and Consumer Health divisional investment projects
• throughout all project phases
• Create and manage a separate C&Q schedule in consideration of and in close coordination with internal and external interfaces
• Actively contribute in the project team and regularly report to the project team on the current status of C&Q activities
  
• Develop and document an overarching project C&Q concept as well as support commissioning activities and related document creation
• Collaborate in the creation of User Requirement Specifications (URS) and support the performance of Quality Impact Assessments and GMP
• Risk Assessments
• Timely create C&Q-relevant documents such as commissioning plan, qualification plans, test plans/protocols and qualification reports
• Interpret and apply relevant internal and external standards/regulations/guidelines/best practices and if applicable, develop and align
• project-specific solutions
• Define contractual services and assign external C&Q service providers in coordination with procurement
  

Profile

• Master or Bachelor degree in engineering sciences, preferred in the area of pharmaceutical engineering, biotechnology or food/process
• engineering
• Initial practical experience as C&Q Engineer (m/f/d) in a project and GMP environment
  
• Knowledge of Good Manufacturing Practice (GMP) as well as current knowledge of relevant regulations and guidelines
• Very good communication skills and team spirit
• Independent, structured and goal-oriented work style in planning and executing activities
  
• Ability to manage ambiguities and conflicts
• High problem-solving competence as well as skills in adequately structuring, simplifying and imparting complex circumstances
• Fluent German and English language skills, both written and spoken