Boehringer Ingelheim Associate Director, Validation in FREMONT, California
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Associate Director, Quality Validation at Boehringer Ingelheim Fremont, Inc. in Fremont, CA.
Job Duties: Lead the Quality Validation group, with a focus on patient safety and product quality. Lead cross-functional and network level teams to deliver validation documentation and strategies to support current and future product licensing and ongoing production for BI internal and client projects. Represent BIFI Validation in BioBU. Play an active role in developing and implementing global procedures as a part of Global Quality and Compliance within BioBU. Propose and execute cross-functional improvements. Develop, review and approve validation plans, protocols, and reports that support the validation of multi-product bulk and Drug Product manufacturing processes. Review and interpret data for accuracy of process performance for completed validations/revalidations and reviews/approves final report packages. Provide technical input to validation deviations and provide assessments for change requests for direct impact systems and identify requirements to ensure the validated state is maintained. Provide technical support and guidance to team members in protocol preparation, execution and data interpretation. Present the validation approach and protocol results to management, contract customers as required. Assist or interact with regulatory agencies. Present and defend GMP documentation associated with quality practices.
Work Schedule: 40 hours per week (8:00am to 5:00pm)
Job Requirements: Masters (U.S. or foreign equivalent) in Scientific discipline such as Chemical Engineering, Biotechnology, Biochemical Engineering, Biomedical Engineering, Biology, Chemistry or Biochemistry. OR Bachelors (U.S. or foreign equivalent) in Scientific discipline such as Chemical Engineering, Biotechnology, Biochemical Engineering, Biomedical Engineering, Biology, Chemistry or Biochemistry. Eight (8) years of experience (with Masters) in the pharmaceutical industry. OR Ten (10) years of experience (with Bachelors) in the pharmaceutical industry. Prior work experience must include six (6) years working in validation. Prior work experience must include the following: Performing validation activities associated with process and cleaning validation in the pharmaceutical industry in a Current Good Manufacturing Practice (CGMP) environment; Understanding and implementing US and EU regulatory requirements for quality and compliance; Direct experience managing teams in a dynamic environment; Multidisciplinary project management and business administration; and Reading and interpreting Piping and Instrumentation Diagrams (P&ID), equipment schematics, sequence of operations, design specifications, functional specifications, process development and characterization of documents.
Organization: US-BI Fremont
Title: Associate Director, Validation
Requisition ID: 1813733