Senior Engineer I, CQV & Drug Product Engineering (Biotech)

Location: 100% onsite in Melbourne, Australia, supporting Clayton Drug Product manufacturing operations.

Company

hirify.global develops an mRNA technology platform and infrastructure for creating and delivering medicines.

What you will do

• Support commissioning, qualification, and validation of GMP Drug Product Fill & Finish equipment, including filling lines, autoclaves, parts washers, and associated process systems.
• Coordinate qualification activities from protocol preparation through execution, technical assessment, documentation review, issue resolution, and closeout, including IQ, OQ, and PQ.
• Act as technical system owner for assigned equipment, maintaining operational readiness, reliability, lifecycle performance, and GMP compliance.
• Provide engineering support for aseptic manufacturing, troubleshooting equipment and process-system issues and supporting investigations, remediation, maintenance, and return-to-service activities.
• Support PPQ, media fills, temperature mapping, scale-up, equipment-readiness assessments, technical risk evaluations, change controls, CAPAs, and deviations.
• Coordinate with Manufacturing, Maintenance, Automation, Validation, Quality, Facilities, vendors, and service providers on projects, audits, continuous improvement, and equipment lifecycle activities; use Generative AI and digital tools where appropriate.

Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 10+ years of relevant experience in pharmaceutical or biotechnology manufacturing, Drug Product Engineering, Commissioning, Qualification & Validation, or a related technical field.
• 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.
• Ability to provide independent engineering judgment, technical direction, risk evaluation, cross-functional coordination, and support for inspection-ready records.

Nice to have

• Experience with aseptic Fill & Finish 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.

Culture & Benefits

• In-person, site-based working model with direct collaboration, mentorship, and hands-on partnership.
• Competitive healthcare and voluntary benefit programs, plus fitness, mindfulness, and mental health support.
• Family-building benefits covering fertility, adoption, and surrogacy support.
• Paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs, with benefits varying by employment nature and country.