Senior Validation Associate

About the company/role:

• A leading provider to the healthcare market.
• Seeking a Senior Validation Associate to join their Melbourne-based technical operations team.
• Full-time permanent opportunity.
• South East of Melbourne.

Duties:
Reporting to the Quality Manager, your duties may include:

• Drive the implementation and ongoing maintenance of the Validation strategy
• Support the Quality Assurance Manager in the implementation of the validation strategy, and guide the Validation and Quality Associate in its execution.
• Maintain key site Validation documents including the Validation Master Plan, Equipment and Process Validation
• Act as Site Subject Matter Expert for the validation function.
• Represent the Validation function in regulatory (TGA and notified bodies) and client audits as required.
• Accountable for writing, executing & reporting of validation
• Prepare Validation Summary Reports for the qualification and validation of systems used in the manufacturing site.
• Coordinate the qualification and re-qualification of critical equipment and utilities, including but not limited to autoclave, hot air steriliser and filling machines.
• Support Non-Conformance, deviation, CAPA and change control processes relating to validation in accordance with the QMS.

About you:

• Bachelor’s degree in Science, Engineering, Technology, or a related discipline.
• Minimum of 4 years’ experience as a validation engineer/specialist in a cGMP environment
• Experience in Facility, Equipment, Utility and Cleaning validation will be highly regarded (preferably in a multi-product facility).
• Strong understanding of GMP requirements, validation principles and regulatory expectations.
• Experience authoring technical documentation including validation protocols, reports, risk assessments and change controls.

Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Deborah on [03 9040 1630](tel:03 9040 1630).

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.