Validation Specialist

Exergy Smeaton Grange, New South Wales, AustraliaThis range is provided by Exergy. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.Base pay rangeA$105,000.00/yr - A$120,000.00/yr$105,000 - $120,000 + superUnique ground-floor career growth opportunity in new manufacturing facilityWill be mentored by experienced Head of QualityExergy is a new business, backed by an established company, with the mission to become Australia''s highest-quality manufacturer of complementary and compounded medicines. It has a brand-new, purpose-built, state-of-the-art manufacturing facility and has recently obtained a TGA manufacturing licence.This is a rare and exciting ground-floor opportunity to join a business from the very beginning from the qualification of new equipment and validation of processes, and systems to enable the launch of our first batch to market . Youll be a foundational part of a growing company with long-term career growth potential as we scale up operations.We are seeking a Validation Specialist to join our team and play a critical role in establishing our quality and compliance frameworks. Reporting directly to the Head of Quality, you will be responsible for validation and calibration activities onsite.Initially, your primary focus will be the qualification of equipment and process and cleaning validation in alignment with the Validation Master Plan. As the facility transitions into full-scale production, your responsibilities will evolve into a more traditional validation role, supporting ongoing life cycle validation activities for equipment, processes, and systems across the site.Apply now to be part of the founding team at Exergy and help us set the benchmark for quality in the Australian pharmaceutical landscape.This is an on-site role in Smeaton Grange. The salary will be negotiated inside the posted range based on your experience and seniority level. This role is best suited for a person in the mid to senior level of seniority who is looking to take the next step.The ResponsibilitiesCollaborate across the business to ensure validation activities align with business objectives;Perform validation and calibration activities for the site;Assist with maintaining a robust and compliant Validation Master Plan (VMP) in conjunction with the Validation Master Schedule (VMS) and ensure effective monitoring and adherence to the schedule;Ensure that all manufacturing equipment and critical utility systems used in the facility are fully qualified according to the Validation Master Schedule. Escalated any potential challenges or delays and reprioritised validation activities according to updated and approved schedules;Ensure Quality Risk Management is applied to all validation activities as appropriate;Prepare validation protocols and reports as per standard operating procedures for Qualification and Validation Documentation and other relevant associated validation procedures;Ensure the successful execution and completion of validation activities associated with new and existing equipment and processes;Collate, review, and data check results for validation reports;Ensure OOS, Deviations and Incidents, and non-conformance are appropriately investigated, and root cause analysis has been performed and appropriately documented;Escalate any significant quality issues and/or Out of Specification results that may impact product quality or regulatory compliance to the Head of Quality;Participate in the technology transfer process of NPD to commercialisation with cross-functional teams;Identify calibration requirements and acceptance criteria for measuring equipment. Ensure all calibration certificates comply with acceptance criteria or are appropriately investigated to ensure the facility remains in a compliant state;Prepare and review change controls as appropriate, providing justification if validation is determined to be not required;Participate in inspections that are performed by the TGA or other regulatory agencies in the area of responsibility;Maintain an electronic filing system of all Quality documents pertaining to the area of responsibility;Develop company SOPs and other controlled procedures and documents as appropriate;Demonstrate strong technical knowledge and understanding of each manufacturing and packaging process;Work with key stakeholders such as Production to ensure appropriate scheduling and completion of validation activities and documents.The Technical Skills and RequirementsTertiary qualification in pharmaceutical sciences, science, or engineering is preferred;Minimum 2 years experience in pharmaceutical or complementary medicines industries, mainly in the areas of validation and quality assurance;Proficient computer skills in Word, Excel, and PowerPoint;Broad experience of validation activities and sound understanding of the principles of quality assurance and quality control functions;Excellent knowledge of cGMP and PIC/S guide, including proven experience in process and cleaning validation;Demonstrate strong technical knowledge and understanding of the inter-relationship of quality attributes and process parameters;Experience in the technology transfer process from NPD to commercialisation for complementary medicine will be highly regarded;Australian Permanent Resident or Citizen with the current right to work in Australia.The Core Competency RequirementsExcellent verbal and written communication skills;Excellent interpersonal, time management, and organisational skills who demonstrates ability to work independently;Positive and proactive attitude.Cross-functional problem-solving and decision making.*Please no recruiters and agencies. We are filling this role in-house.*Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionManufacturing, Quality Assurance, and EngineeringIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Exergy by 2xGet notified about new Validation Specialist jobs in Smeaton Grange, New South Wales, Australia.Oakdale, New South Wales, Australia 5 days agoHomebush, New South Wales, Australia A$70,000 - A$100,000 4 days agoHomebush, New South Wales, Australia A$70,000 - A$100,000 4 days agoParramatta, New South Wales, Australia 2 weeks agoQuality Improvement Specialist Aged Care ServicesBankstown, New South Wales, Australia $115,100 - $130,000 3 weeks agoElectrical Product Development - Quality AssuranceWere unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Created: 2025-07-03