California, United States of America
- Responsible for oversight of the Cleaning Validation program.
- Develop, and optimize project based resources assessments in addition to the validation strategies for equipment, utility systems, automation systems, processes and facilities.
- Leverage risk management principles to drive risk based validation testing and decision making. Executes / Leads the assessment for multi product risk as a result of introduction of new products to the existing manufacturing facility. This may include the assessment of cleaning validation requirements as part of the New Product Introduction program to ensure our multi product status is maintained.
- Author, review and approve Validation Master Plans, Project Plans, Protocols and Summary reports; and maintain compliance with PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
- Provide oversight to validation testing, sample collection, result analysis and preparation of summary reports and ensure the quality of completed work.
- Prepare, and review specific validation summary sections of regulatory submissions and technically defend the cleaning validation strategies to regulatory authorities during routine and pre-approval inspections.
- Participate in and/or lead implementation of continuous improvement initiatives within Validation to maintain a state of inspection readiness, regulatory compliance, and process efficiency.
- Develop internal audit and regulatory observation responses, and corrective action for validation deficiencies as required.
- Bachelors degree (Life Science, Engineering)
- Minimum of 5-7 years (Sr. Validation Engineer E3) / 8-11 years (Sr. Technical Manager E4) of direct validation experience in a cGMP environment with increasing levels of responsibility for a wide range of validation projects.
- Must have demonstrated Validation experience relative to large scale biochemical manufacturing equipment, utility and automation systems.
- Must have thorough technical knowledge of Equipment/Facilities/Utilities Qualification (IQ/OQ/PQ) and Cleaning Validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
- Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones, budgets and schedules.
- Requires Strong technical writing, mechanical aptitude, verbal communication, interpersonal and problem solving skills.
- Ability to work independently, organize and manage individual as well as lead larger scale projects.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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