CSV Engineer

One of our clients, a global biopharmaceutical client is looking for a CSV Specialist to join their team on their site in Sydney, Australia on a long term contract.

The successful candidate will be responsible for ensuring all GxP systems, processes and equipment within the Supply and Manufacturing Division are commissioned, validated and maintained in accordance to all applicable regulatory and corporate requirements. The person fulfilling this role will be a member of the Technical Services team and will have projects and responsibilities in line with the broader working umbrella of this group within the Quality function.

DUTIES

Technical:

• Write/develop validation protocols and reports (IQ/OQ/PQ/PPQ) for Capital and BAU Projects
• Consult and conduct risk assessments associated with validation activities, OCM or CAPAs
• As an SME, assist with review and execution of validation activities relating to OCM and CAPAs
• Ensure equipment systems and processes are appropriately validated in line with relevant framework, approved procedures, protocols and schedules.
• Assist with the review and enhancement of existing validation documentation, where appropriate.
• Perform Data integrity assessments for applicable systems and follow through with mitigation actions thereof.
• Train personnel and keep up to date with developments within industry and cGMP requirements for validation.
• Contribute to development, standardisation and simplification of local procedures to align with global standards.

Operations:

• Consult and coordinate project and/or production staff, activities and schedules for all assigned projects that fall in line with business objectives.
• Develop and implement work action plans to ensure projects are delivered, meeting project timelines.
• Effective time management, aiming to achieve the key business objectives
• Effective equipment resource planning and cost management

REQUIREMENTS

• Qualifications in Science, Engineering or Quality related discipline.
• Minimum of 3 years in a pharmaceutical or related industry manufacturing environment in Production, Engineering or Quality Assurance.
• Minimum 2 years in Validation.
• Attention to Detail, Analytical Thinking, Drive and Determination, Multi-Tasking.
• Test Protocol development & Report writing.
• Clear and effective communication with relevant departments.
• Problem Solving and conducting risk assessments.
• Commitment and passion for Compliance and Quality, with attention to detail and ability to speak up while remaining uninfluenced.
• Knowledge of regulation requirements within a pharmaceutical manufacturing environment
• Knowledge of sterilisation, cleaning, computer validation and process automation

 


If this sounds like the opportunity you are looking for then please apply today!




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