We are seeking engineers to support the manufacturing process, continuous process improvement initiatives, identify areas for enhancement and implement effective solutions.
About Your Role
You will be responsible for:
* Ongoing compliance with relevant legislation and standards governing our business, sterilisation and manufacturing operations.
* Studying and maintaining detailed reports and statements of quality assurance, quality control and process operational activities.
* Establishing standards and policies for installation, modification, quality control, testing, inspection and maintenance according to engineering principles.
* Maintaining the site’s products, components and equipment and process inspection, calibration and preventative maintenance programs.
* Ensuring compliance with safety and regulatory standards and driving continuous improvement initiatives.
* Assist in specification control and developing specifications, incoming QC and inventory monitoring of critical process consumables.
* Preparation of processed loads for dispatch and validation documentation.
About You
Candidates with experience in a quality function within a pharmaceutical, manufacturing, general healthcare or other highly regulated industry are preferential but not required.
You will have:
* Qualifications in Mechanical, Electrical, Biomedical, or similar Engineering, or related equivalent experience (essential).
* Awareness of the general principles of sterilisation, validation, GMP manufacturing and related microbiology (desirable).
* Sound understanding of Good Manufacturing Principles and Quality Management System requirements (GMP PIC/S, ISO13485, ISO11137) (desirable).
* Knowledge and experience in TGA Audits and/or other regulatory bodies (desirable).
* Sound judgment and decision-making abilities, often under pressure (essential).
* Solid level of attention to detail (essential).
* Effective communication skills and the ability to collaborate with internal teams and external stakeholders (essential)
Successful candidates will be required to undergo Pre-employment Checks, including a Medical and Police Records check.
Are you ready to apply for this role? Click Apply! Please apply as soon as possible as applications will be shortlisted when they are received, and interviews may commence prior to the closing date.
Role Type
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