Job from partnerWe are seeking a motivated and detail-oriented Process Engineer to join a growing advanced manufacturing organisation operating in the medical device and pharmaceutical sector. This is a 12-month contract opportunity, with strong potential for extension or transition to a permanent role.
About the Role
As a Process Engineer, you will be responsible for developing, implementing, validating, and maintaining manufacturing processes for complex medical device and combination products. You will work cross-functionally with engineering, R&D, and production teams to deliver robust, scalable, and compliant processes that meet business and regulatory requirements.
This is a hands-on role combining process development, validation, and ongoing production support, with a strong focus on quality, efficiency, and continuous improvement.
Key Responsibilities
- Develop and implement reliable, validated manufacturing processes for both clinical and commercial production
- Lead process design activities including mapping, simulations, optimisation, and equipment selection
- Collaborate with multidisciplinary teams (R&D, automation, engineering) to support product and process development
- Prepare technical documentation such as process flow diagrams, specifications, and validation protocols
- Execute validation activities including IQ, OQ, PQ, risk assessments, PFMEA, and test method validation
- Support commissioning, qualification, and ongoing improvement of manufacturing processes
- Manage communication with internal stakeholders, suppliers, and external partners
- Ensure all processes and documentation comply with relevant quality and regulatory standards
About You
- Bachelor’s degree in Engineering (Mechanical, Mechatronics, Electrical, Biomedical, or similar)
- 2–5 years’ experience in a regulated manufacturing environment (medical device and/or pharmaceutical preferred)
- Strong understanding of process development, validation, and quality systems
- Experience with automated manufacturing equipment and process optimisation
- Knowledge of ISO standards and regulatory requirements
- Ability to work both independently and within cross-functional teams
- Strong communication, problem-solving, and project management skills
- Proven ability to manage competing priorities and meet deadlines
Desirable Experience
- Experience with commissioning, qualification, and validation (CQV) activities
- Familiarity with lean manufacturing principles
- Experience working within an ISO-certified Quality Management System
- Exposure to high-volume or scale-up manufacturing environments
- Experience preparing SOPs, work instructions, and validation documentation
Why Join Us?
- 12-month contract with strong potential for extension or permanency
- Work on cutting-edge technology in a rapidly growing industry
- Collaborative and supportive team environment
- Opportunity to contribute to innovative healthcare solutions
Apply now or reach out for a confidential discussion to learn more about this opportunity
At KE Select, we specialise in the recruitment of scientific, medical, and technical professionals across Australia and New Zealand. We are committed to connecting talented individuals with leading organisations and supporting long-term career growth.
