Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. In this role, you will provide hands‐on engineering support for critical mRNA drug product manufacturing and fill‐finish systems within a fast‐paced 24x7 GMP manufacturing environment. You will play a key role in ensuring equipment reliability, compliance, operational readiness, and continuous improvement across highly automated and technically advanced production systems.
Responsibilities
* Provide hands‐on technical support for mRNA drug product manufacturing and fill‐finish equipment to ensure operability, reliability, compliance and business continuity.
* Support and maintain critical process equipment including single‐use mixers, parts washers, autoclaves, isolators, filling machines and supporting utility systems.
* Ensure all in‐scope equipment consistently meets compliance, safety, GMP and operational performance requirements.
* Respond to alarms, out‐of‐specification (OOS) and out‐of‐trend (OOT) events while conducting product impact assessments and initiating containment actions as required.
* Represent Engineering during Tier 1 Operations meetings to review, prioritize and address equipment issues impacting product quality and overall equipment effectiveness (OEE).
* Track engineering action items, communicate issue resolution status and escalations of unresolved or critical operational risks appropriately.
* Lead root‐cause investigations utilizing 5 Why and Fishbone analysis to identify equipment failure modes and implement CAPAs.
* Develop and support associated change controls linked to equipment improvements, remediation activities and reliability initiatives.
* Collaborate closely with mechanical and electrical Process Technicians to troubleshoot and resolve failures involving drives, valves, sensors, control loops and utility distribution networks.
* Support commissioning, qualification and validation activities for new and modified equipment including development and execution for URS, IQ, OQ and PQ protocols.
* Maintain and update cGMP documentation including SOPs, SWPMs, batch records and engineering records to ensure inspection readiness and operational compliance.
* Support internal and external GMP audits through technical documentation review, issue resolution and engineering representation.
* Liaise directly with OEM vendors for equipment installations, commissioning activities, warranty support, technical escalations and troubleshooting.
* Coordinate with internal and third‐party calibration teams to schedule, verify and maintain calibration status for critical instrumentation and process equipment.
* Support engineering projects through all project lifecycle phases including user requirements, design reviews, procurement, installation, startup, commissioning and operational handover.
* Analyze equipment reliability metrics, operational performance trends and CMMS data to identify opportunities for optimization and continuous improvement.
* Recommend and implement enhancements to preventive maintenance strategies, equipment reliability programs and operational effectiveness initiatives.
* Contribute to a highly collaborative engineering environment focused on innovation, technical excellence, operational agility and continuous learning.
* Operate effectively within a country remit supporting Moderna's Australian manufacturing operations and broader business objectives.
Qualifications
* Bachelor's degree in Chemical, Mechanical, Mechatronics or a related engineering discipline.
* 2–4 years of relevant experience in pharmaceutical or bioprocess manufacturing in a GxP/GMP environment preferred.
* Exposure to drug‐product equipment such as mixers, isolators, filling lines, autoclaves, parts washers and automated inspection and packing machines preferred.
* 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.
* Excellent interpersonal and communication skills; ability to present technical findings and influence cross‐functional teams.
* Self‐starter with strong problem‐solving skills, adaptability for 24x7 operations and eagerness to learn under mentorship.
* Professional demeanor; able to represent Moderna's interests and policies.
* Position is site‐based and requires full‐time presence at Moderna's Melbourne site. Remote work is not available.
Pay & Benefits
* Best‐in‐class healthcare plus voluntary benefit programs to support unique needs.
* Holistic approach to well‐being with access to fitness, mindfulness and mental health support.
* Family‐building benefits including fertility, adoption and surrogacy support.
* Generous paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days and discretionary year‐end shutdown.
* Savings and investments to help plan for the future.
* Location‐specific perks and extras. Benefits may vary by employment nature and country.
Work Conditions
This position may be subject to pre‐employment and periodic medical assessments in line with relevant legal and operational requirements.
Work hours include a 24x7, 7 days a week, 365 day year schedule requiring flexible, adaptable performance.
Equal Opportunity & Reasonable Accommodation Notice
Moderna is committed to equal opportunity in employment and non‐discrimination for all employees and qualified applicants regardless of a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status or any other characteristic protected by law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in the hiring process and/or to perform the essential functions of the position should contact the Accommodations and Adjustments team at .
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