Process Engineer

Role OverviewA leading pharmaceutical company based in the Waterford area is currently seeking a dedicated Validation Engineer to support a new project. As the Validation Engineer, you will play a crucial role in ensuring the ongoing validation and compliance of new equipment, systems, and processes.Key Duties And ResponsibilitiesYour duties as the Validation Engineer will be varied; however, the key duties and responsibilities are as follows: Executing FAT/SAT/IOQ protocols, including the generation of protocols and reports. Designing, executing, and reporting on validation studies for equipment, systems, and processes. Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.). Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.Role RequirementsTo be successful in your application to this exciting role as the Validation Engineer, we are looking to identify the following on your profile and past history: Relevant degree in a scientific or engineering discipline. Proven industry experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector. A working knowledge and practical experience with validation protocols, quality management systems, and regulatory compliance.Key WordsValidation Engineer / Pharmaceutical / Waterford / FAT / SAT / IOQ / cGMP / Aseptic Processing / Lyophilisation / Sterilisation / Depyrogenation / Quality Management / Regulatory Compliance / Equipment Validation / Process ValidationHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.