Sr. Validation Engineer

SR. VALIDATION ENGINEERCAMPBELL, CA Required Skills:

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws, codes, regulations and regulatory requirements.
• Pharmaceutical principles, practices and applications.
• Pharmaceutical quality control and manufacturing processes.
• Principles and practices of qualification and validation.
• Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
• Mechanical and electrical concepts.
• Personal computer operations and Microsoft applications (Word, Access, and Excel).
• Analyzing problems, identifying alternative solutions, projecting consequences of proposed actions and implementing recommendations in support of project completion and goals.
• Interpreting software and ladder logic diagrams and flowcharts.
• Enterprise systems experience (e.g. ERP, LMS, and QMS).
• Software Validation
• Knowledge of US and International regulations-
• Customer Interactions skills.

• Primary projects include, performing alarm criticality assessments, including post assessment mitigation; data process mapping, system risk assessments, data flow risk assessments, and lab equipment qualification.
• Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related computer system or equipment, and assures that protocols are approved per procedures.
• Executes validation and qualification protocols, test scripts and final/summary reports per applicable SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
• Interacts with all effected personnel in the execution of protocols and gathering of test data. Assures that all test data is gathered and recorded in accordance with GxP requirements. Manages data integrity related validation projects including interacting with applicable departments.
• Reviews and assist System Owner and Business analyst to draft software/computer specifications and requirements.
• Analyzes data to ascertain if it meets related protocol acceptance criteria. Writes deviation reports as required upon failures to meet protocol acceptance criteria.
• Complies with all GxP and safety requirements, SOPs and Company policies and procedures.
• Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements.
• Develops and communicates project timeline and status.
• Coordinates resources from Business Technology, engineering, technical services, quality assurance and Business owners assigned to specific validation projects.
• Performs related duties as assigned.