Validation Engineer

Posted: 02/02/2024 Closing Date: 07/03/2024 Job Type: Permanent - Full Time Location: Prestons, NSW Job Category: Technical About us At PharmaCare, we inspire people to be the best, healthiest and happiest they can be.

As an Australian born and built success story we are proud of our heritage and remain a 100% Australian owned and family operated business. We are home to some of Australia’s most well-known and trusted brands including Nature’s Way, Bioglan, Sambucol, Norsca, Brut, Skin Doctors, Naturopathica, KP24, Aquasun, Promensil, BioMedica, Medlab and many more.

  PharmaCare has tripled its work force and production output over the last 3 years. Our rapid growth has seen massive investment committed to our operation with $20M planned over the next 24 months. Recent developments have seen the operation double its footprint with further expansion on the horizon.

Our success comes from our performance led culture, and we want our people to succeed. We encourage ownership and integrity with an entrepreneurial flair. Based in Prestons, we live the life we promote.

We are family owned with a global reach, our products are found in pharmacies, supermarkets, department and variety stores all over the world. Extras we know you’ll love: Generous monthly complimentary products to support your health and wellbeing Paid parental leave, subsidised health and salary continuance insurance Employee assistance/wellbeing initiatives Ongoing training and development programs Secure onsite parking Work life balance – knowing “downtime” is as important as “uptime” Leave loading.

Job Description About the role  PharmaCare Operations is looking for a Validation Engineer to be responsible for the Validation of processes and equipment used within PharmaCare Operations (DQ, IQ, OQ & PQ).  This role requires knowledge of current GMP requirements with regards to the documentation and validation; with a large focus on drafting, owning, executing, reviewing and reporting validation documents for PharmaCare Operations.

Reporting to the Validation Manager, your key responsibilities include but are not limited to: Preparing and executing Engineering Studies in preparation for Validation activities. Preparing and updating validation documents. Participating in and documenting validation and compliance risk criticality assessments.

Executing qualification and validation protocols. Review and analyse qualification or validation data/results. Prepare validation reports.

Maintain records and files of validation work. Become familiar with production processes and methods by building productive relationships with Production, Engineering, Maintenance and Quality. Observe production, developmental and experimental activities to understand detailed operating procedures and methods to create effective Validation protocols.

Recommend changes to manufacturing processes to enhance and improve efficiencies. Provide support to small and medium sized operational projects as required. Provide support to operational investigations related to equipment and process failures.

Perform Validation Reviews, Re-Qualification or Re-Validation; to maintain all validated systems in their validated state. Assist in the management of validation register/database. Assist on other appropriate validation…