5285 Validation Engineer
The Validation Engineer IV position is responsible for defining qualification / validation strategies and coordinating testing activities required to complete assigned projects in support of the operation of the Vacaville Commercial Manufacturing Facility.
Performance of such validation activities include Equipment/Utility/Facility Qualification, Cleaning Validation, Steaming/Sanitization/Sterility Validation and Automation System Qualification across the entire validation lifecycle from Plan to Retire.
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.
Author Master Plans (Site and Cleaning), Project Plans, Protocols and Summary reports; and maintain compliance with development and deployment new PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
Reviews Validation Protocols, Commissioning Plans, analyzes test results, and reviewed summary reports.
Represent the department on project teams and coordinates activities of Manufacturing Sciences and Technology, Manufacturing, Quality, and other Vacaville groups required to manage projects.
Ensure validation documentations is consistent with industry regulations and standards when supporting projects as a contractor.
Participate in the development of internal audit and regulatory observation responses, and corrective action for validation deficiencies as required.
Participates in the efforts to evaluate gaps, develop remediation plans and driving remediation through the CAPA system for development and deployment new Roche PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
Providing technical assessments and validation review of Automation Functional Requirements, Control Qualification testing (recipes, I/O, control module etc.), P&IDs, engineering changes and associated start-up documentation; in addition to validation review for engineering, process and standard operating procedure changes Promotes good interdepartmental relations.
Training is maintained to ensure job responsibilities can be performed on a daily basis.
Has advanced knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
Strong technical writing, verbal communication, interpersonal and problem solving skills.
Ability to work independently, organize and manage individual as well as lead larger scale projects and track progress against defined milestones, budgets and schedules.
Possesses thorough knowledge to prepare regulatory summaries.
Bachelors degree (Life Science, Engineering).
Minimum 9 years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large scale biochemical manufacturing, utility and automation systems.