CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required. Responsibilities Validation Work closely with the Validation manager to ensure completion of validation goals and objectives. Support validation projects from initiation to completion, ensuring they are delivered on time and within budget. Support the testing and validation of equipment, cleaning processes, analytical processes, and software. Support the development and implementation of validation plans, protocols, and procedures. Evaluate and approve validation plans, protocols, and reports to ensure completeness and accuracy. Ensure that all aspects of validation, testing, and documentation are completed in a timely and efficient manner. Utilise effective risk management to maintain product quality and compliance. Identify potential risks associated with validation processes and support the development of mitigation strategies. Conduct risk assessments to identify potential issues in products and processes. Establish and maintain validation procedures and processes that meet company policies and applicable regulations. Work to schedules for validation activities to ensure timely execution and completion. Participate in the tracking, reporting and trending of validation activities and results. Ensure management is aware of validation department performance, trends in products/processes, and changes that could impact the facility. Track and trend processes to monitor validation department performance. Work closely with cross‑functional teams to resolve validation issues and to ensure all products and processes are validated accurately and efficiently. Support compilation and review of Product Quality Reviews/A Annual Product Reviews, as appropriate. Communicate with internal and external stakeholders regarding projects, products, and other validation related topics. Perform other job‑related duties as assigned. Regulatory Compliance Responsible for compliance with relevant regulations, legislation, and standards. Support preparation efforts for regulatory inspections and audits related to validation activities. Support the generation of audit responses to observations in a clear and holistic manner. Support the company Data integrity program. Support the inspection readiness program. Knowledge of relevant TGA and regulatory guidelines to ensure cGMP compliance. Training and Development Proactively foster an open, supportive, values‑based culture, and work environment. Utilise a broad understanding of cGMP to provide Validation support, mentoring and coaching for Quality, Operations, Analytical, Logistics and Engineering departments. Other Duties Identify continuous improvement opportunities and implement solutions to improve programs and meet business goals. Participate in internal meetings/events/activities as required. Qualifications A bachelor’s degree in a relevant field such as engineering, life sciences, or quality assurance is essential. Advanced degrees or certifications in validation or quality systems can be advantageous. Demonstrated experience in Validation in a relevant or related industry. Minimum of 2 years of experience in validation, quality assurance, or a related field. Strong understanding of FDA, EMA, and ISO regulations including PDA and ISPE pertinent to validation activities. Proficiency in validation management software such as or similar tools is required. Experience with electronic documentation systems and risk management tools is also beneficial. Good project management skills for supporting validation projects effectively. Excellent analytical skills to assess validation data and identify trends. Familiarity with relevant technology and systems used in validation processes, including software validation, equipment qualification, and process validation techniques. Ability to adapt to changing regulations, technologies, and industry standards. Good knowledge of CGMP and GMP regulatory requirements nationally and internationally. Excellent attention to detail and decision‑making skills. Demonstrated knowledge and understanding of quality management principles and a commitment to fostering a culture of quality and compliance. #J-18808-Ljbffr