Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Key Responsibilities:

• Planning and scheduling of required resources (manpower, spares and consumables) for all maintenance and calibration related activities associated with site utilities, facilities and equipment in alignment with GMP and internal quality standards.
• Coordinating with cross-functional departments including engineering, quality control, operations, and quality assurance to obtain access to equipment for maintenance and calibration ensuring minimal equipment and production downtime.
• Organizing and managing contractors to perform maintenance and calibration eensuring all work is performed and documented correctly in relation to site EH&S guidelines and data integrity record keeping practices
• SME for site CMMS software (MEX) utilising MEX to plan maintenance/calibration, manage assets, and maintain accurate maintenance records, ensuring traceability and compliance with GMP and Thermo Fisher’s quality management standards.
• Implementing continuous improvement processes for effective planning, allocation of work, and execution of maintenance/calibrations.
• Assist with purchasing with relation to preventative maintenance/calibration/spare part inventory
• Maintain departmental spreadsheets, Smartsheet etc., for KPI reporting and assisting with the development and maintenance of quality documentation and engineering standards
• Support site audits and inspections (internal and external) by providing key maintenance and calibration information.
• Participate in Failure Mode & Effect Analysis (FMEA) exercises and analyze equipment performance data to forecast maintenance needs and optimize resource allocation.
• Investigate deviations and collaborate with cross-functional teams to identify root causes and implement Corrective and Preventative actions (CAPAs).
• Drafting and updating Standard Operating Procedures (SOPs), managing change requests, deviations and CAPAs via the GTW system
• Support new equipment registration and equipment lifecycle processes.
• Any other task assigned by the Team Leader/Supervisor/Manager.      

Frequent Contacts:

Internal

• Engineering, Operations, Quality Control, Quality Assurance, Warehouse

External

• Vendors, Contractors, Visitors

Minimum Requirements/Qualifications:

Qualifications & Experience

• Diploma or Bachelor's degree in Engineering, Biotechnology, Science, or a related technical field (or equivalent practical experience).
• Relevant experience in maintenance planning, engineering administration, or technical support within a regulated manufacturing or industrial environment.
• Experienced user of electronic documentation systems (e.g., MEX CMMS, SAP ARIBA, Catalyst, Smartsheet, GTW).
• Solid understanding of Good Manufacturing Practices (GMP), especially within pharmaceutical or biologics manufacturing settings.
• Knowledge and hands-on experience in environmental health & safety (EH&S) practices within industrial or manufacturing facilities.
• Familiarity with facilities and utilities used in biologics manufacturing, including equipment maintenance and calibration requirements.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook) and digital collaboration tools.

Skills & Attributes

• Strong attention to detail and ability to manage documentation in compliance with regulatory and quality standards.
• Effective communication and coordination skills, especially in cross-functional team environments.
• Ability to work independently, manage priorities, and meet deadlines in a dynamic work setting.
• Proactive approach to problem-solving and continuous improvement initiatives.

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
• Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law
• Your position may require you to participate in on call work. If you are on call you are required to be available for immediate return to work outside of your normal and regular work pattern. Should this be a requirement of your position, you will be remunerated per the Company’s policy.