Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.
We are seeking a Validation Engineer who will be responsible for the creation, execution, documentation, reporting and administration of validation protocols for manufacturing processes, equipment, facility, cleaning and computer systems. Validation activities require structured quality risk management, in accordance with current regulatory requirements and industry best practices.
Ensure compliance to all validation lifecycle requirements
Creation and maintenance of Validation Project Plans, including Site Validation Master Plan
Validation Protocol Preparation including URS, DQ, IQ, OQ & PQ.
Execution of Validation activities and report preparation
Integration of Quality Risk Management into all validation activities
Validation review and scheduling of revalidation activities
Co-ordinate validation and commissioning of new equipment
Bachelor's degree in Science, Engineering or related discipline
5 years experience in a similar role within the Pharmaceutical or Complementary Medicines industry
Knowledge of, and ability to interpret validation principles and regulatory
Experience in process, cleaning, equipment, facility and computer system
Knowledge of continuous improvement and risk based methodologies
Excellent Communication and Organisational skills
Demonstrated effective Project Management and superior Computer Literacy
Statistical software skill competency, desirable
OTC facility experience; desirable
Good written and verbal communication skills together with knowledge of basic computer word processing, spreadsheets, MRP and SAP software systems could make you the successful candidate for this role.
If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.
Only applicants selected for interview will be contacted.
All other applicants are thanks for their interest.