Principle Engineer Cleaning Validation

Organization: 
Bayer
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
1. Primary responsibility is to provide effective leadership in the management of large and complex cleaning validation projects: define scope of work, bid out project, as needed, procure resources and successfully manage validation projects to completion. This includes management of projects at multiple sites, including cleaning validation technology transfer to international supply centers; and projects of strategic importance to the business unit.
2. Forms, leads and manages the cleaning validation team through all stages of validation: planning, procurement, qualification, validation and continuous monitoring. Leads the team through the process of validation to ensure that all compliance and regulatory requirements are met. Work requires knowledge and leadership in interaction with validation, quality andoperations groups involved in cleaning validation and implementation of cleaning validation strategies in operations.
3. Recognized as a cleaning validation expert within the PS organization. Determine and establish validation requirements for a wide range of processes, systems and equipment, consistent with corporate directives and regulatory expectations. Develops validation strategy for the project and coordinates strategic and tactical aspects of the validation workstream.
Develop and maintains validation SOPs and other governing documents to ensure consistent application of the requirements
and strategies. Writes, reviews and approves standard operating procedures describing validation principles and activities.
4. Actively leads during all phases of cleaning validation project planning and execution: evaluates projects and provides technical and project guidance to support the project. Writes reviews and approves validation documents to support FAT, verification, IOQ, PQ, PV activities. Develops and implements high level cleaning validation strategies and documents
strategies in Validation Master Plans.
5. Initiates and enforces necessary improvements and corrections; leads team meetings to ensure validation project success. Oversees contractors and site personnel within the cleaning validation project team, ensuring that they have the appropriate skill set and required trainings and are meeting performance expectations.
6. Manages engineering drawings (P&IDs, against as-built) and TOP documentation. Controls the generation of validation documents and procedures related to facilities, equipment, systems, utilities, laboratory equipment, and process validation in order to ensure compliance with corporate standards, regulatory requirements and industry expectations. Performs validation compliance audits of cleaning validation at receiving site during technology transfer to ensure successful regulatory audit and licensure.
7. Reviews validation packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Escalates critical deviations to Quality and Site management’s attention. Recommends when to accept and release qualified systems to production, as well as when not to do so.
8. Establishes priorities and schedule activities to ensure timelines and milestones are met. Leads budget planning and control throughout lifecycle of cleaning validation project to ensure project success.

Requirements:
Your qualifications
B.A. or B.S. in Engineering, Biology, Biochemistry, or related science
Minimum 10 years of experience in Validation ,Quality or Operations Departments.
Or an equivalent combination of education and experience managing cleaning validation projects.
• Cleaning validation leadership experience required. Including leading multiple complex cleaning projects simultaneously and ability to influence at the executive level in the organization.
• Cleaning validation project experience including: definition of scope of work, validation project budgeting, validation project bidding process, validation contractor management.
• Provides strategic technology transfer direction including VMPs, VPs, Process, Cleaning, Shipping, Analytical, Facility Computer system
and Equipment validation.
• Knowledge of the regulatory (FDA, EMEA and international regulations) and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices, especially as it relates to cleaning validation.• Validation compliance knowledge including regulatory audit experience required. Experience with auditing of cleaning validation systems preferred.
• Proven experience completing validation projects within time, budget that also meets or exceeds quality standards. Including defining and managing budget and resources.
• Excellent verbal and written communication, interpersonal and communication skills required. Including ability to influence department heads.
• Demonstrated ability to develop and present site-wide training sessions.
• Acts as technical expert in the field of validation, including one or more of the following areas: Process Validation, Cleaning Validation, Shipping Validation, Performance Qualification, Media Fills, Air Flow Visualization, Lyophilization, Process Equipment, Process
Development, Facility Qualification.
• Must be recognized as an expert in cleaning validation and aware of existing regulatory guidance and expectations related to cleaning
validation.
• Desirable to have experience establishing and maintaining cleaning validation programs.
• Must have experience implementing cleaning validation methodologies in multi-product
biopharmaceutical facilities, including methods for establishing worst case soils, coupon study experience, MACO calculation methodologies, different methods for establishing acceptance criteria including toxicological and general limits, soil recovery studies and soil and cleaning
agent measurement assay selection.
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.