CAI is looking for individuals with experience in commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
Position Overview
The Validation Specialist will work closely with the Validation Manager to ensure completion of validation goals and objectives, support validation projects from initiation to completion, and contribute to maintaining compliance with applicable regulations.
Validation Responsibilities
* 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, within budget, and coordinated with cross‐functional teams.
* Test and validate equipment, cleaning processes, analytical processes, and software.
* Develop, implement, evaluate, and approve validation plans, protocols, and reports to ensure completeness and accuracy.
* Ensure timely and efficient completion of all validation, testing, and documentation activities.
* Apply effective risk management, identify potential risks, develop mitigation strategies, and conduct risk assessments.
* Establish and maintain validation procedures and processes that meet company policies and applicable regulations.
* Schedule validation activities to ensure timely execution and completion.
* Track, report, and trend validation activities and results, and communicate performance, trends, and changes to management.
* Resolve validation issues in collaboration with cross‐functional teams and integrate validation activities into the overall project lifecycle.
* Support the compilation and review of Product Quality Reviews / 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
* Ensure compliance with relevant regulations, legislation, and standards.
* Support preparation for regulatory inspections and audits related to validation activities.
* Generate audit responses to observations in a clear and holistic manner.
* Support the company Data Integrity program and inspection readiness program.
* Apply knowledge of TGA and regulatory guidelines to maintain cGMP compliance.
Training and Development Support
* Foster an open, supportive, values‐based culture and work environment.
* Provide validation support, mentoring, and coaching for Quality, Operations, Analytical, Logistics, and Engineering departments to ensure cGMP and internal procedure compliance.
Other Duties
* Identify continuous improvement opportunities and implement solutions to improve programs and meet business goals.
* Participate in internal meetings, events, and activities as required.
Requirements
* Bachelor's degree in engineering, life sciences, or quality assurance is essential; advanced degrees or certifications in validation or quality systems are advantageous.
* A minimum of 2 years of experience in validation, quality assurance, or related field.
* Strong understanding of FDA, EMA, ISO regulations, including PDA and ISPE.
* Proficiency in validation management software and experience with electronic documentation systems and risk management tools.
* Good project management and analytical skills, with ability to assess validation data and identify trends.
* Familiarity with software validation, equipment qualification, and process validation techniques.
* Knowledge of cGMP and GMP regulatory requirements nationally and internationally.
* Excellent attention to detail, decision‐making skills, and a commitment to quality and compliance.
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