02 Oct
|
Mayne Pharma Australia
|
Salisbury
02 Oct
Mayne Pharma Australia
Salisbury
Are you an experienced Manufacturing Engineer who wants to play a key role in improving manufacturing performance, equipment reliability and operational efficiency in pharma? Join Mayne Pharma as our Manufacturing Engineer.
Reporting to the Engineering Manager, you'll lead capital and continuous improvement projects across our manufacturing area and provide day-to-day technical support to Production and Maintenance. You'll work across Production, Maintenance and Quality to solve equipment and process problems, bring new equipment and products online, and make sure engineering work is delivered safely and in line with pharmaceutical regulatory requirements.
What you'll do
- Lead capital and continuous improvement projects from scoping, cost estimates and timelines through to execution and reporting, delivering on time and on budget.
- Provide hands-on technical support to Production and Maintenance, troubleshooting equipment and process issues to keep manufacturing running.
- Lead commissioning of new plant, equipment and processes, and support qualification and validation activities (IQ/OQ/PQ).
- Prepare and maintain GMP engineering documentation, including change controls, risk assessments, commissioning records, SOPs, P&IDs; and equipment specifications.
- Lead root cause investigations into equipment and process issues and implement effective CAPA.
- Apply Lean and Six Sigma principles to reduce waste and variability and to improve process robustness and performance.
- Strengthen equipment reliability by optimising preventive maintenance programs and using EAM/CMMS data to analyse asset performance.
- Support New Product Introductions and commercial product transfers,
making sure equipment is capable and technically ready.
- Identify and develop improvements to production flows, equipment and automation.
- Work with suppliers and contractors on equipment design, procurement, installation and commissioning.
- Train operators and Maintenance team members on recent equipment, processes and safety requirements.
- Support internal audits and regulatory inspections, including TGA and FDA, as well as site sustainability initiatives such as energy and waste reduction.
All engineering activities are undertaken in line with GMP, WHS, environmental requirements and our quality systems.
What you'll bring
- Tertiary qualifications in an Engineering discipline.
- Engineering experience in pharmaceutical, food and beverage, medical device or another highly regulated manufacturing environment.
- Experience with manufacturing equipment, capital projects, commissioning and/or continuous improvement.
- A working understanding of GMP and engineering in a regulated environment, with strong attention to detail in documentation and change control.
- Strong analytical and problem-solving skills, with a practical approach to finding solutions.
- The drive to work independently and take ownership, combined with the communication skills to work well across Production, Maintenance, Quality and other teams.
- Experience with Lean, Six Sigma, EAM/CMMS systems, or equipment qualification and validation will be highly regarded.
- We select people based on capability and aptitude, with a strong emphasis on cultural fit: a positive mindset, a practical approach and a willingness to own your performance.
Ready to become part of the Mayne Pharma story? How To Apply — Click the APPLY NOW button.
📌 Manufacturing Engineer (Salisbury)
🏢 Mayne Pharma Australia
📍 Salisbury