Senior Engineer I, CQV & Drug Product Engineering
Moderna · Melbourne, Australia · onsite
The Role
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.
This individual-contributor role provides technical engineering leadership and hands-on support for commissioning, qualification, validation readiness, and routine GMP manufacturing operations within Drug Product Fill & Finish at Clayton.
You will serve as a critical technical interface between Commissioning, Qualification & Validation (CQV) and Drug Product Engineering, supporting the qualification, operational readiness, reliability, and lifecycle management of filling lines, autoclaves, parts washers, and associated process systems.
Combining engineering expertise, cGMP knowledge, independent technical judgment, and cross-functional problem-solving, you will help ensure equipment performance, manufacturing readiness, regulatory compliance, and continuous improvement throughout the equipment lifecycle.
Here’s What You’ll Do
- Support commissioning, qualification, and validation activities for GMP Drug Product manufacturing equipment, including filling lines, autoclaves, parts washers, and associated process systems.
- Coordinate equipment qualification activities from preparation through execution and closeout, including qualification protocol preparation, execution support, technical assessments, documentation review, and resolution of qualification-related issues.
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, as applicable to assigned equipment and projects.
- Serve as technical system owner for assigned Drug Product manufacturing equipment, ensuring continued operational readiness, equipment reliability, lifecycle performance, and compliance with GMP requirements.
- Provide day-to-day engineering support for aseptic Fill & Finish manufacturing operations, troubleshooting equipment and process-system issues and providing technical direction for investigations and resolution.
- Serve as a technical interface between CQV and Drug Product Engineering, ensuring qualification activities remain aligned with manufacturing requirements, operational priorities, project schedules, and regulatory expectations.
- Coordinate engineering and qualification priorities to support manufacturing schedules, equipment readiness, operational continuity, and critical project milestones.
- Support Process Performance Qualification (PPQ), aseptic process simulations, including media fills, and manufacturing scale-up activities.
- Lead and support equipment-readiness assessments, qualification impact assessments, and technical risk evaluations associated with Drug Product manufacturing systems.
- Support first-air protection initiatives and identify engineering improvements associated with aseptic processing, equipment design, and protection of critical processing environments.
- Coordinate temperature-mapping studies and associated qualification activities in collaboration with Validation, Engineering, and Facilities.
- Partner closely with Manufacturing, Maintenance, Automation, Validation, Quality, and Facilities to troubleshoot equipment issues, assess technical risks, and develop appropriate remediation strategies.
- Support equipment modifications, engineering changes, and return-to-service activities, evaluating potential impacts to equipment qualification, validated processes, and ongoing manufacturing operations.
- Support and own Change Controls, CAPAs, and Deviations as assigned, including technical investigations, impact assessments, root-cause evaluation where applicable, and implementation of corrective actions.
- Ensure compliance with GMP requirements and associated controlled documentation, including SOPs, qualification protocols, technical reports, equipment records, and engineering assessments.
- Maintain accurate, complete, and inspection-ready cGMP records, both paper-based and electronic, in accordance with Moderna's Quality System.
- Provide technical expertise for assigned Drug Product manufacturing equipment and support equipment lifecycle management from initial qualification and operational readiness through routine GMP manufacturing operations.
- Partner with Maintenance and Facilities to support preventative and corrective maintenance activities, strengthen equipment reliability, and maintain operational readiness.
- Identify and implement continuous-improvement opportunities related to equipment performance, qualification execution, manufacturing efficiency, operational reliability, and engineering ways of working.
- Coordinate cross-functional Engineering and CQV activities, ensuring alignment of technical deliverables, qualification execution, project schedules, resources, and manufacturing priorities.
- Lead assigned engineering projects and qualification workstreams as an individual contributor, providing technical direction and coordinating cross-functional resources to support safe, compliant, and timely execution.
- Support the scheduling and planning of engineering, qualification, and manufacturing-readiness activities.
- Collaborate with equipment vendors and service providers to support technical assessments, equipment troubleshooting, qualification activities, maintenance needs, and resolution of equipment-related issues.
- Provide technical input into equipment specifications, engineering assessments, qualification strategies, system improvements, and equipment optimization initiatives.
- Support regulatory, partner, and internal audits by providing technical documentation, equipment qualification records, engineering assessments, and subject-matter expertise for assigned systems.
- Apply independent engineering judgment to identify technical and compliance risks, prioritize activities, evaluate options, and recommend solutions that protect equipment compliance and continuity of manufacturing operations.
- Support knowledge transfer and provide technical guidance to engineering colleagues, qualification personnel, manufacturing stakeholders, and other cross-functional partners as appropriate.
- Look for opportunities to work with Generative AI and other digital tools to accelerate technical knowledge retrieval, support engineering analysis, strengthen troubleshooting workflows, and improve the efficiency of documentation and equipment-lifecycle activities, while operating within Moderna's applicable quality, data, and compliance requirements.
- Perform other duties as required in support of Clayton Drug Product manufacturing operations.
The key Moderna Mindsets you’ll need to succeed in the role:
- “We act with dynamic range, driving strategy and execution at the same time at every step.”
- “We behave like owners. The solutions we’re building go beyond any job description.”
Here’s What You’ll Need (Basic Qualifications)
- Education: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- Experience: 10+ years of relevant experience in pharmaceutical or biotechnology manufacturing, Drug Product Engineering, Commissioning, Qualification & Validation, or a related technical field.
- Specific Certifications or Training: Working knowledge of cGMP requirements, equipment qualification practices, validation lifecycle principles, and pharmaceutical manufacturing quality systems. Familiarity with IQ/OQ/PQ, change controls, deviations, CAPAs, and GMP documentation requirements.
- Other Quantifiable Preference: Experience supporting aseptic Fill & Finish manufacturing equipment, including filling lines, autoclaves, parts washers, and associated process systems. Experience with PPQ readiness, media fills, temperature mapping, equipment qualification, manufacturing technical support, and cross-functional project execution preferred.
Our Working Model
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