Manager, Validations

Bayer HealthCare Pharmaceuticals is a global leader in the research, development, manufacturing and commercialization of innovative biotechnology and specialty pharmaceutical products that improve human health. Our growing presence on the West Coast of the United States includes campuses at Berkeley, Emeryville and Richmond, California and Seattle, Washington.As the sixth largest biotechnology company in the world, Bayer has more than 20 years of experience bringing complex protein-based therapies to market. The Bay Area is a global center for Bayer's biotechnology initiatives, and global functions of Bayer's pharmaceutical business. Bayer is the second largest biotechnology employer in the Bay Area; Berkeley is the headquarters of Bayer's global biotech manufacturing organization. The company's US research team is based in Richmond while development teams are based at Berkeley. The company's three primary supply centers for protein therapies are Berkeley (Kogenate®), Emeryville (Betaseron®) and Seattle (Leukine®).We are currently looking to fill the position of Validation Manager at our Seattle site.This position is responsible for the management and compliance oversight of the validation program for the Seattle site operations. Manages the validation functions within Quality by providing technical input from the quality point of view for the aspects of validation, and production. This position also has responsibility for partnering with contract facilities to promote, facilitate and ensure compliance with cGMP and corporate validation standards1. Responsible for the leadership and management of the validation department activities, including budgeting and budget compliance at Seattle site operations.2. Develops a comprehensive Master Validation Plan to identify equipment and processes that require validation for product licensure. Establishes timelines with milestones and rate limiting steps clearly identified.3. Manages the preparation and execution of validation protocols and reports and assures that all validation documentation is as required. Maintains the production in compliance with cGMPs as it relates to processes, equipment, facilities and computer systems. Provides technical input for all aspects of facilities, products and quality systems.4. Develops validation acceptance criteria and provides necessary in-house training in validation activities. Acts as the communication interface with quality management relating to validation information and status.5. Works towards compliance with computer validation requirements associated with equipment and instrument qualifications. Utilizes available information and internal tools (i.e., internal and external audit findings, FDA 483 observations, failure investigations) to identify validation program deficiencies, recommend changes to meet regulatory requirements.6. Primary representative during interaction with FDA investigations.Estimates validation resources and costs based on projectPOSITION REQUIREMENTSBachelor’s degree BS in Science and experience in regulated industry is required with a minimum of six + years experience cGMP’s; Biological Mfg.