Science, Pharmaceutical & Food
- Full Time
Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures
Essential Duties and Responsibilities include, but are not limited to, the following:
• Responsible for all aspects of the Validation programs onsite for a large scale Biopharmaceutical Drug Substance production facility.
• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• 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 controls, SOPs, reports and other documentation.
• Collaborates with functional departments to resolve issues.
• Trains/advises less experienced Specialists..
• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• Manage and drives projects and prepares status reports.
• May present at both internal and external (regulatory) audits
• Stays current with industry trends, regulatory requirement updates, and communicating same to team
• May manage full time employees and/or contingent workers.
• Performs other duties assigned by Management.
• Some travel may be required.
Education and Experience:
• BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the field of Cleaning Validation in Biopharmaceutical, Aseptic Fill/Finish or API manufacturing;
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.