Job description

About Us

Arna Pharma is a multi-faceted pharmaceutical company committed to revolutionizing the pharmaceutical and life sciences industry. With a focus on drug development, research and manufacturing, Arna Pharma empowers our business partners with world-class capabilities to create safe, effective, and innovative healthcare solutions."

Role Description

This is a full-time on-site role for a Process Improvement and Validation Engineer at Arna Pharma’s manufacturing site located in Frenchs Forest, NSW. The role will be responsible for day-to-day tasks related to process control, business process improvement, and utilizing analytical skills to enhance manufacturing operations.

Qualifications and Competences

• A tertiary degree in engineering, a related technical discipline, or experience/competencies that provide an equivalent level of knowledge
• GMP manufacturing: Experience working within a GMP-regulated environment.
• Pharmaceutical engineering: Exposure to, and relevant educational background relevant to, equipment, services, and facilities used for the manufacture of pharmaceuticals or similar products.
• Validation: Experience preparing and/or reviewing validation documentation in the pharmaceutical industry.
• The ability to work independently, including prioritization of tasks and organization of time.
• The ability to understand technical matters and to relate them to the context in which they occur.
• Ability to communicate technical concepts and their relevance/importance to people from a wide range of technical backgrounds.
• Excellent technical writing skills.
• Attention to detail.

MAIN DUTIES/RESPONSIBILITIES:

Engineering Support

• Contributing to incident investigations, risk assessments, and similar activities that may require input from multiple perspectives, including an engineering perspective.
• Reviewing maintenance and calibration records, and other records of routing Engineering department activities.
• Devising and implementing modifications/improvements to equipment/systems,
• Selecting, procuring and installing new equipment, and completing pertinent Change Control activities,
• Preparation and/or review of documentation, e.g. procedures, records and reports.

Maintenance

• Arranging and/or undertaking routine, planned maintenance activities for production equipment.
• Arranging and/or undertaking repair/rectification works in response to equipment breakdowns,
• System administration of automated/computerized systems and their associated management/record/documentation systems, and day-to-day operation of such systems, as required,

Operations

• Identifying modification/improvement opportunities,
• Source suitable suppliers, for both new equipment/systems and parts for existing equipment/system and perform vendor approval. Liaise with directly and manage such suppliers.
• Specifying, designing and planning modifications/improvements. Providing advice regarding the feasibility of, and works required for, possible Operation.

Validation

• Preparing validation documents, e.g. validation planning documents, specifications, equipment qualification protocols and reports, and process validation protocols and reports.
• Reviewing validation documents prepared by others.
• Executing validation studies, or supervising/witnessing the execution of validation studies by others.
• Providing advice regarding validation-related matters to others within organization.

Quality Systems Compliance

• Compliance with all applicable procedures.
• Correct completion and handling of all applicable quality records.
• Preparation/review of quality system documentation (SOPs, Forms, etc.) as necessary to maintain an appropriate standard of quality.

Safety Compliance

• Ensure all work – including that of contractors – is performed in a safe manner in accordance with the Arna Pharma WHS Policy,
• Maintain the company’s equipment/facilities in a safe state, as directed by the Arna Pharma Safety Team.
• When implementing new equipment or new system to Production/Engineering, ensure a risk assessment is performed and all risks mitigated, where possible, prior to handover for use.