Senior Engineer I, CQV & Drug Product Engineering

Moderna Therapeutics Inc.; Melbourne; In loco; AUD 140.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare

Well-being programs

Family building benefits

Paid time off

Descrizione del lavoro

Moderna Therapeutics Inc. is seeking an experienced engineer for leadership in commissioning, qualification, and validation of GMP Drug Product equipment at Clayton. You will coordinate IQ/OQ/PQ activities, ensure equipment readiness, and support aseptic Fill & Finish manufacturing with cross‑functional teams.

The role emphasizes technical judgment, cGMP compliance, and lifecycle management of manufacturing systems, including prevention of issues and enabling continuous improvement.

Competenze

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 10+ years of relevant experience in pharmaceutical manufacturing, Drug Product Engineering, CQV, or related technical field.
• Working knowledge of cGMP requirements, equipment qualification practices, validation lifecycle principles, and GMP documentation.
• Experience supporting aseptic Fill & Finish manufacturing equipment, PPQ readiness, media fills, and temperature mapping.

Mansioni

• Support commissioning, qualification, and validation activities for GMP Drug Product manufacturing equipment, including filling lines and related systems.
• Coordinate equipment qualification activities from preparation through execution and closeout.
• Support IQ, OQ, and PQ activities for assigned equipment and projects.
• Serve as technical system owner for Drug Product manufacturing equipment to ensure readiness and compliance.
• Provide day-to-day engineering support for aseptic Fill & Finish operations and investigations.
• Own Change Controls, CAPAs, and Deviations, including technical investigations and corrective actions.

Conoscenze

CQV interface

Engineering leadership

GMP knowledge

Aseptic Fill & Finish

PPQ readiness

IQ/OQ/PQ

Cross-functional collaboration

Formazione

Bachelor’s degree in Chemical Engineering

Strumenti

IQ/OQ/PQ protocols

Qualification lifecycle

Descrizione del lavoro

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

As we build our company, we have always believed that an in‑person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site‑based operations. Working onsite enables real‑time collaboration, strong team connections, direct mentorship, and the hands‑on partnership needed to deliver our mission.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.

Pay & Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A 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 a discretionary year‑end shutdown
• Savings and investments to help you plan for the future
• Location‑specific perks and extras
• The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world‑class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Equal Opportunity Statement

Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to 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 personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Reasonable Accommodation Notice

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at [e-mail].