Process Validation Engineer

Job Description

Get AI-powered advice on this job and more exclusive features. About Us Arna Pharma is a multi-faceted pharmaceutical company committed to revolutionizing the pharmaceutical and life sciences industry. With a focus on drug development, research and manufacturing, Arna Pharma empowers our business partners with world-class capabilities to create safe, effective, and innovative healthcare solutions. Role Description This is a full-time on-site role for a Process Improvement and Validation Engineer at Arna Pharma’s manufacturing site located in Frenchs Forest, NSW. The role will be responsible for day-to-day tasks related to process control, business process improvement, and utilizing analytical skills to enhance manufacturing operations. Qualifications and Competences A tertiary degree in engineering, a related technical discipline, or experience/competencies that provide an equivalent level of knowledge. GMP manufacturing: Experience working within a GMP-regulated environment. Pharmaceutical engineering: Exposure to, and relevant educational background relevant to, equipment, services, and facilities used for the manufacture of pharmaceuticals or similar products. Validation: Experience preparing and/or reviewing validation documentation in the pharmaceutical industry. The ability to work independently, including prioritisation of tasks and organisation of time. The ability to understand technical matters and to relate them to the context in which they occur. Ability to communicate technical concepts and their relevance/importance to people from a wide range of technical backgrounds. Excellent technical writing skills. MAIN DUTIES/RESPONSIBILITIES: Contributing to incident investigations, risk assessments, and similar activities that may require input from multiple perspectives, including an engineering perspective. Reviewing maintenance and calibration records, and other records of routine Engineering department activities. Devising and implementing modifications/improvements to equipment/systems. Selecting, procuring and installing new equipment, and completing pertinent Change Control activities. Preparation and/or review of documentation, e.g. procedures, records and reports. Maintenance Arranging and/or undertaking routine, planned maintenance activities for production equipment. Arranging and/or undertaking repair/rectification works in response to equipment breakdowns. System administration of automated/computerised systems and their associated management/record/documentation systems, and day-to-day operation of such systems, as required. Operations Identifying modification/improvement opportunities. Source suitable suppliers for both new equipment/systems and parts for existing equipment/system and perform vendor approval. Liaise with directly and manage such suppliers. Specifying, designing and planning modifications/improvements. Providing advice regarding the feasibility of, and works required for, possible Operation. Validation Preparing validation documents, e.g. validation planning documents, specifications, equipment qualification protocols and reports, and process validation protocols and reports. Reviewing validation documents prepared by others. Executing validation studies, or supervising/witnessing the execution of validation studies by others. Providing advice regarding validation-related matters to others within organization. Quality Systems Compliance Compliance with all applicable procedures. Correct completion and handling of all applicable quality records. Preparation/review of quality system documentation (SOPs, Forms, etc.) as necessary to maintain an appropriate standard of quality. Safety Compliance Ensure all work – including that of contractors – is performed in a safe manner in accordance with the Arna Pharma WHS Policy. Maintain the company’s equipment/facilities in a safe state, as directed by the Arna Pharma Safety Team. When implementing new equipment or new system to Production/Engineering, ensure a risk assessment is performed and all risks mitigated, where possible, prior to handover for use. If you’re interested in this position, please send your resume to . Seniority level Entry level Employment type Full-time Job function Quality Assurance Industries Pharmaceutical Manufacturing #J-18808-Ljbffr