The primary responsibility of the Principal Engineer position is to focus on Commissioning and Qualification activities on Bayer Business and Technology Services managed capital projects to primarily support the HealthCare business.
Bayer recognizes that science plays an integral part in everyday life and encourages all employees to make a difference through daily contributions to our organization’s mission. Careers with Bayer allow for the experience of working in a global environment with an on-going focused effort and sustainable approach to improving lives of humans and animals. Related to this position, Bayer offers the opportunity to:
Be part of the Commissioning and Qualification group within Project Management & Engineering (PME) which is responsible for the following project activities to support the HealthCare business.
The primary responsibilities for the incumbent of this role will be:
• Provide effective leadership in the planning and management of the commissioning and qualification aspects of projects to support commercial manufacturing: define scope of work, bid out project, procure resources and successfully manage commissioning and qualification activities to completion. This includes management of projects at multiple regional and global sites;
• Generation of commissioning and qualification documents related to facilities, equipment, systems, utilities, laboratory equipment in order to ensure compliance with corporate standards, regulatory requirements and industry expectations;
• Generation of validation strategy, cost and schedule estimates for conceptual projects;
• Establish and communicate priorities and schedules activities to ensure milestones are met;
• Leads budget planning and control throughout the capital project.
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer Business and Technology Services (BBTS) seeks an incumbent who possesses:
• Bachelor’s Degree in the Chemical, Biochemical or Mechanical Engineering field and eight or more (8+) years of experience OR;
• Master’s Degree in the Engineering field and six or more (6+) years of experience OR;
• PhD in the Engineering field and four or more (4+) years of experience AND;
• Eight or more (8+) years of experience with Engineering in GMP regulated environment direct experience in qualification of process systems;
• Supervisory and managerial experience;
• Ability to lead, develop, and maintain good working relationships with employees from diverse disciplines;
• Demonstrated ability to provide practical, specific guidance to colleagues regarding the knowledge of appropriate compendia/industry guidance and regulatory requirements;
• Ability to effectively develop and communicate requirements with rationale to all levels of the organization;
• Ability to work with colleagues to solve engineering ‘problems’ in a practical/ timely manner;
• Understanding of biotechnology processes and knowledge of mechanical systems and clean utilities
• Strong written and verbal skills;
• Tolerance for constant high level of challenge;
• Display excellent organizational, presentation, and interpersonal skills;
• Experience in project scheduling, budgeting and cost control.
• Familiarity with ASTM-E2500 & GAMP;
• Knowledge of ICH/ISO/ISPE C&Q Baseline Guide/PDA Technical Reports, etc.;
• Knowledge of CFR requirements/ EU/ JP/ MHRA/ Canada and how to apply these requirements;
• Knowledge of Risk management and Risk Analysis Tools, e.g. ICH 8, 9, 10;
• Knowledge of best practices in the industry for development of engineering standards for pharma/biotech design/construction/operation/maintenance.