Manufacturing Engineer

Mayne Pharma Australia; City of Salisbury; On-site; AUD 90,000 - 120,000; Full time

Job summary

Mayne Pharma Australia is seeking an experienced Manufacturing Engineer to drive performance, reliability and efficiency in our pharmaceutical manufacturing environment in South Australia. You will lead capital projects, provide hands-on technical support to Production and Maintenance, and collaborate across Production, Maintenance and Quality to ensure GMP and regulatory compliance.

You will spearhead commissioning of new plant and equipment, support IQ/OQ/PQ activities, and develop robust

Qualifications

• Tertiary qualifications in an Engineering discipline.
• Engineering experience in regulated manufacturing environments.
• Experience with capital projects and continuous improvement.
• GMP awareness with strong documentation discipline.
• Strong analytical and problem-solving skills.
• Ability to work across Production, Maintenance and Quality.

Responsibilities

• Lead capital and continuous improvement projects from scoping to execution.
• Provide hands-on technical support to Production and Maintenance.
• Lead commissioning of new plant, equipment and processes and support qualification/validation (IQ/OQ/PQ).
• Prepare GMP engineering documentation including change controls and SOPs.
• Lead root cause investigations and implement CAPA.
• Apply Lean and Six Sigma to reduce waste and improve performance.
• Strengthen preventive maintenance and analyze asset performance using CMMS data.
• Support New Product Introductions and product transfers.

Skills

Analytical skills

Problem-solving

Independent worker

Cross-functional collaboration

Education

Engineering degree

Tools

CMMS

GMP documentation

Job description

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 new 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?