Job no.: 494828
Work type: Full Time Permanent
The Opportunity: The Validation Associate will be responsible for creating and executing validation processes for all existing and new equipment, ensuring the processes are in line with best practice and evolving regulatory expectations.
What you will do: Manage our validation and requalification programs, examining current validation processes and recommending improvements. Responsible for implementation and ongoing improvement of validation policies and procedures within the company Quality Management System, along with providing technical expertise within those functional areas. Responsible for oversight and execution of validations for production, manufacturing and cleaning processes. Develop/review and approve validation protocols and final reports and ensure compliance with cGMP and current regulatory requirements. Define, support and guide validation activities. Responsible for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities, and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards. Review change requests for impact to validation and support QA compliance activities such as Product Quality Review. Maintain Revalidation Plan and all manufacturing, while ensuring all revalidation is performed and reported. Prepare and maintain Validation Master Plans for the facility, utility, and equipment to ensure they are all adequately validated for cGMP projects undertaken within the facility. What we are looking for: Tertiary qualifications in Science, Engineering, or related discipline. Thorough knowledge and understanding of validation requirements in a cGMP facility and Validation Lifecycle Approach. Experience in process validation execution and Equipment Qualification. Preferred experience in cleaning validation, utilities qualification and computerised systems validation. Competent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standards. Why us? This is a unique opportunity to work in a company where you are valued, given the recognition you deserve and suitably rewarded for your hard work.
Other benefits include:
Employee Share Plan Company Paid Parental Leave Employee Assistance Program for Mental Health Wellbeing Staff Awards Employee Referral Program Health Insurance Discounts Working in our state-of-the-art, purpose-built facility, built to GMP standards. Flexible working options including hybrid working model and flexible start and finish times (within reason). We are committed to fostering a workplace that values diversity and inclusion. As an equal opportunity employer, we actively strive to build a gender-equitable team and cultivate a culture that embraces individuals from all walks of life. We welcome applications from candidates of diverse backgrounds, abilities, ages, and cultures (including First Nations Peoples).
Our commitment to inclusivity extends to supporting candidates with disabilities throughout the recruitment process. If you require any accommodations due to disability, please inform us by reaching out to We believe that a diverse and inclusive workforce enriches our organisation and contributes to our success.
Pre-employment checks may be required and will be discussed with the successful candidate.
If you believe that you have the necessary attributes to succeed in this challenging and rewarding role.
No agency assistance will be required. Advertised: 13/12/2024 E. Australia Standard Time
Applications close: 10/01/2025 E. Australia Standard Time
#J-18808-Ljbffr