Production Engineer
On-site · Melbourne, Victoria, Australia
Job Summary
The Production Engineer will provide hands-on technical support to ensure operability, reliability, and compliance of mRNA drug-product manufacturing and fill-finish equipment in a 24×7 GMP environment. Responsibilities include maintaining single-use equipment (mixers, parts washer, autoclave, isolator, filling machine, utilities), responding to alarms and quality events, leading root-cause analyses, coordinating with OEM vendors and calibration teams, assisting with commissioning, qualification, and validation protocols (URS, IQ/OQ/PQ), maintaining cGMP documentation, and supporting continuous improvement and maintenance strategies. The role requires a Bachelor’s degree in an engineering discipline, 2–4 years of pharmaceutical/bioprocess manufacturing experience, familiarity with PLC/HMI/SCADA systems, CMMS, and strong communication and cross-functional collaboration skills.
Required Qualifications
- Bachelor’s degree in Chemical, Mechanical, Mechatronics or related engineering discipline
- 2–4 years of relevant experience in pharmaceutical or bioprocess manufacturing (GxP/GMP environment preferred)
- Exposure to drug-product equipment is preferred (mixers, isolators, filling lines, autoclaves, parts washers, automated inspection and packing machines)
- Basic hands-on troubleshooting of PLC/HMI/SCADA systems, variable-speed drives, and pneumatic/vacuum loops
- Experience assisting with CQV activities and drafting validation deliverables
- Familiarity with CMMS, Excel (pivot tables, charts), Word, and PowerPoint
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