Principal Engineer

Job Location: 
Berkeley, CA
Job Description: 

Bayer HealthCare (BHC), an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.

Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement “Bayer: Science For A Better Life".

Job description
Production Support
o Optimizes production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements.
o Provides key technical input for the definition of concepts for new plants, improvement of existing equipment and/or the identification of alternative equipment or installations
o Ensures production equipment uptime through preventive or predictive measures as well as small modifications and repairs
o Ensures reliability of Production Unit process equipment, facilities and utilities
o Provides the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment
o Development, optimization and overall quality of work plans, processes and standards
o HES compliance - supports Bayer Berkeley's commitment to safety by complying with the programs regarding health, safety and protection of the environment. The incumbent demonstrates safe work practices, contributes to safety meetings, provides input to relevant personnel (e.g., operators, supervisors, technicians) regarding safety issues and ensures resolution of non-conforming conditions.
o Demonstrates high level of urgency and is able quickly adapt to changing priorities Maintenance / Reliability
o Establishes, initiates and analyzes preventative maintenance (PM) and calibration programs
o Collection, analysis and reporting of equipment downtime information oIdentifies, reports and ensures resolution of critical equipment items
o Develops, reviews and implements recommendations to improve reliability of infrastructure and production systems.
o Responsible for maintaining the Calibration, Maintenance and Safety procedures in defined area of responsibility.
o Specification and strategy of spare parts needed to meet reliability objectives.
o Coordination of maintenance activities and shutdown requirements for FPM production equipment and facilities.

Project Support, Execution and Management
o Project management and detailed engineering of smaller projects (AFE, <$1 million) including planning, detailed design, procurement, construction management, quality, budget and optimization.
o Provides plant and production input and project engineering support for large projects, (AR, >1 million)
o Ability to perform installation and operational commissioning and qualification testing of
equipment and systems. Experience with FAT, SAT, Commissioning and Qualification, including hands on experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages, etc.
o Understands and ensures all relevant procedures for operation, commissioning and qualification are followed.
o Planning and organization of cross-functional activities
o Contributes to project planning and execution for facility modifications and enhancements
o Acts as key technical resource on multi-disciplinary projects and activities.

cGMP Compliance
o Participating in audits conducted by internal and external agencies
o Resolution of Quality action items, write Engineering Assessments as Subject Matter Expert(SME)
o Performing Risk Assessments and resolution of risk analysis
o On-going participation in technical and non-technical training
o Understanding of relevant SOPs, Guidelines and Regulatory requirements

o Assures continuous improvement of processes
o Meets customer needs in support of business goals
o Coaches and teaches junior members of the department and provides input to performance evaluations
o Makes independent decisions within defined areas of responsibility.
o Serves as a consultant to management within a specified area/discipline.
o Advances technical project proposals to senior management, following through to successful completion
o Develops network of external contacts appropriate to job
o Formulates and manages own career path

Your qualifications Requires a Bachelor of Science Degree from an accredited college or university in Chemical, Electrical, Mechanical Engineering, or a closely related field.
BS 8+ years
MS 2-6+ years
PhD 0-4 years
or an equivalent combination of education and experience
Professional registration and/or certifications as appropriate
o Experience with regulatory and cGMP requirements for pharmaceutical manufacturing is required.
o Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems, etc., are required.
o Knowledge of Bulk Formulation, Sterile Filling, Lyophilization, Packaging and Warehouse Technologies
o Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems is required.
o Demonstrated ability to troubleshoot complex equipment / systems and supporting utility services.
o Requires flexibility to support business requirement of rotational on-call support and / or weekend coverage.

Your application
We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.

If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.