Sr Validation Specialist - Cold Chain
Posted on Apr 17, 2019 by Anonymous
With the fastest growing Biotech site in Europe (soon to be the largest as well) and a business model that has the company as one of the best employers in Europe and most financially successful as well, you will find yourself in an experience that will write history in the industry.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
• Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Reviews, edits and approves change control and SOPs.
• Collaborates with functional departments to resolve issues.
• May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department.
• May train/advise less experienced Specialists and Technicians.
• May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
• Assesses quality system documentation for completeness and accuracy, and dispositions documentation within the company's SOPs.
• Manages projects and prepares status reports.
• Interacts with Automation/Process Engineering for managing changes during qualification window.
• Strong communication/presentation skills during internal/external audits.
Experience and Required Skills: Education and Experience:
• BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; will substitute relevant experience for education