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SalaryOur client is a pharmaceutical company producing APVMA approved sterile injectables and TGA approved nonsterile capsules. It was established to advance healthy treatments for osteoarthritis, interstitial cystitis and more.
The Role:
An opportunity for a Full-Time Production Engineer has come available within the framework of the company's production schedule and this position is responsible for ensuring that all manufacturing, production and engineering processes are in compliance with GMP and all equipment is fully functional during manufacturing time frames.
It is for a full-time role with an annual salary of $70,000 plus superannuation at their Bondi Junction workplace.
The successful applicant shall benefit from close mentoring and development from the Production Manager, great growth potential, and professional and social environment.
The Responsibilities:
Assist the Production Manager and General Manufacturing Manager in the manufacture of intermediate and finished products at all stages of production according to established procedures and work instructions in compliance with GMP (Good Manufacturing Practice)
Lead continuous improvement projects with focus on labour productivity, process yield and equipment utilisation.
Utilise accurate data analysis to drive labour cost reduction.
Work closely with Production Manager to improve the production line performance and equipment efficiencies.
Prepare the user requirement specification (URS) and perform the installation / operational qualification (IQ/OQ) and performance qualification (PQ) of new manufacturing equipment.
Assist in the preparation of validation plans for equipment, in conjunction with the General Manufacturing Manager and/or the Production Manager.
Commissioning new manufacturing plant and equipment.
Raise deviations and change requests as required. Provide assistance in the investigation, and identification of relevant preventative and corrective actions.
Assist in the update and review of SOPs, BRFs, and any other document as required by production.
The Requirements:
Minimum bachelor degree in engineering preferably chemical engineering
At least two years of relevant experience as Production Engineer
Good understanding of GMP and sterile manufacturing principles
Certification in Lean Six Sigma (not essential but highly regarded)
Good numeracy and literacy skills
Ability to work to production schedules and meet deadlines
Maintain personal hygiene and personal gowning to Grade A cleanroom standard
