Quality Assurance/Automation Engineer

Quality Assurance Automation Engineer

Melbourne

• European business providing cutting edge process automation technology.
• Opportunity for career growth either in Australia or Overseas.
• Company has a formidable track record in their target industries and within Australia.

Our client is a leader in process technology, known for their design and build of turnkey process plants and robotic systems.

The company is looking to build upon their successes in Australia and are now looking for a Quality Assurance Automation Engineer to join the team in Melbourne to further grow the company's presence across the pharmaceutical & life science industries.

Key responsibilities:

• Creation of templates for qualification-relevant documents in the automation area (CSV) such as FS, DS, FAT, IQ, SAT, OQ.
• Contact point for qualification questions.
• Supporting the project manager in creating the qualification-relevant documents.
• Support the project manager in document management with the customer.
• Can go to site and execute protocols.
• Liaises and engage with both internal and external stakeholders to ensure projects' QA requirements.
• Comply to all aspects of cGMP and ensure stringent adherence to principles.
• Keep knowledge about GMP, GAMP, FDA, 21 CFR Part 11, etc. up to date
• Flexible to assist in the automation area of the company if required, which contains:

• Implementation of process automation, including SCADA and MES solutions
• Develop and implement PLC software solutions for process automation projects
• Prepare functional and design specifications to guide automation projects
• Conduct technical reviews and approve system lifecycle documentation for JAG hardware and software

Required skills & experience:

• Need an automation engineering background.
• Experience in the automation industry.
• Exposure to bio-pharmaceuticals is preferred
• Experience in software quality assurance in a cGMP regulated manufacturing environment.
• Strong knowledge of software QA methodologies, tools, and processes, experience with KNEAT highly valued.
• CSV (computer system validation) experience is highly regarded.
• Skilled in dealing with organisational tasks and IT and PC systems.
• Self-motivated with energy and a positive, analytical mindset with high attention to detail.
• Ability to manage competing priorities and agendas.
• Proven ability to work as a team player with multidiscipline teams, sharing knowledge and ensuring alignment with strategic business goals.
• Bachelor in Engineering preferred.
• French and/or German language skills would be a plus but not essential.
• Ideally Australian citizen / permanent resident or equivalent visa holder, without working restrictions in Australia.

This position offers the chance to join an established global business, with track record across the Pharmaceutical industry. You will be joining an entrepreneurial, collaborative team environment in a highly technical business, looking to leverage their track record in Australia, providing real growth opportunities. A flexible, hybrid working model is available for the successful candidate and extensive in-house training is on offer.

If you have the required skills and ambition to further your career in a market leader, please apply. Applicants must be currently living in and have full working rights in Australia. Only candidates who meet the criteria will be contacted.