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

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

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