This position is responsible for providing technical support to Engineering and Validation teams for equipment, system, and process initial qualification. The individual must have the ability to write reports clearly, concisely and accurately. A basic understanding of current Good Manufacturing Practices (cGMP) is also required to perform these duties.
• Performs equipment commissioning testing in conjunction with Engineering for new equipment.
• Performs validation/qualification studies (utility, equipment, cleaning, process computer, and new products) to include writing Risk Assessments, protocol preparation, scheduling, protocol execution, and final report preparation.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Responsible for managing multiple deviation investigations simultaneously.
• Provides follow up and scheduling to qualification process is not impacted by outstanding deviations.
• Works with process experts and production personnel to fully understand and solve problems,
• Provides technical expertise and recommends improvements.
• Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.
• Maintains compliance with company policies, training requirements, cGMPs and safety standards.
• Perform any other tasks/duties as assigned by Management.
• Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
• 0-3 years’ experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports is also required. Must be familiar with regulatory (FDA) requirements.
• Requires advanced critical thinking and technical writing skills.
• Good organizational, communication, and interpersonal skills are necessary.