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As a Validation Engineer/Senior Validation Engineer at GlaxoSmithKline, you will play a crucial role in ensuring the integrity and compliance of our manufacturing processes. This position involves the creation of a comprehensive Validation Strategy, as well as the preparation and execution of Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Process Validation. These activities must align with the corporate standards of our division. You will also contribute to the development of Site Validation Master Plans, focusing on validation activities in aseptic filling areas, which include the qualification of manufacturing equipment such as autoclaves, washers, tunnels, and Sterilization in Place (SIP) of filling vessels, along with cleaning validation. In this role, you will support all aspects of the Validation Life Cycle in Manufacturing, from design through operation and improvement. You will be responsible for authoring and executing IQ and PQ protocols and reports for equipment and computerized systems across production, quality control, and storage areas on site. Your technical expertise will be essential in reviewing and developing Standard Operating Procedures (SOPs) and providing input for change control to ensure compliance with site needs and industry standards. You will also be responsible for executing the site requalification plan and streamlining testing requirements while maintaining regulatory and corporate compliance. This includes preparing site validation documentation such as qualification protocols, validation master plans, risk assessments, and periodic reviews. Staying current with validation requirements, practices, and procedures is vital, as you will instruct other site members participating in validation studies. Additionally, you will participate in cross-functional teams to address specific problems and enhance interdepartmental relationships, implementing improvement initiatives in filling/packaging and facility/utility qualification activities. As the site validation representative, you will present information and answer questions to regulatory agencies during audits regarding the validation program and specific validation studies. All job responsibilities must be performed in compliance with applicable Environmental Health and Safety (EHS) and Good Manufacturing Practices (GMP) regulations, guidelines, policies, and standard operating procedures.
