Job Description
Melbourne, Australia | Posted on 08/17/2026
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We are looking for a CQV/Fill Finish Engineerto join our team on a 12 -month contract . The CQV/Fill Finish Engineer will play an essential role in supporting theCQV activities and fill finish processes in aGMP
manufacturingenvironment.This
position requires a solid understanding ofCQV andfill & finish processes and the ability to collaborate effectively with project teams. The ideal candidate willbe responsible forassistingin the creation of key documentation, ensuring project milestones are tracked, and providing hands-on support in cleanroom environments.
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DU T I E S A N D R ES P O N SIBI L IT IE S :
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Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
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Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
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Assists to review and qualify equipment for commissioning, qualification, and validation activities.
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Supports to write and review GMP and GDP documents and technical specifications.
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Collaborate with multiple departments on assigned project activities and deliverables.
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Assist to initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
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Ensure system integration with filling lines and compliance with validation requirements.
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Support MES recipe startup , debugging, and documentation updates to align with process optimization efforts.
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Collaborate with client teams, vendors, contractors, and cross-functional stakeholders to deliver project objectives.
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Manage project activities, timelines, and status reporting while ensuring compliance with cGMP and data integrity requirements.
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DEMO N S TR A T E D C O M P E T E N CI ES :
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BusinessDevelopment




- Identify andtarget potential clients. Work in a team environment; develop and execute aplan, in alignment with company vision, mission and strategic plans to engagepotential customers.
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Relationship Building -Works with and across formal and informal professional and social networks tobuild long-term partnerships and connections in the life science industry andInternal team.
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Negotiation Skills -Active listening, needs assessment, and presents visions to build a consensus.
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Analytical Skills -Identifies, researches, and demonstrates logical reasoning to
communicatecritical
information.
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Rational Persuasion -Presents key factors, influencing factors, and strategic goals to assiststakeholders in identifying solutions.
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Interpersonal Awareness - Ability to be aware of how actions, ideas, and
communicationcan/does
affect people and their outcomes.
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Agility - Meets objectives by respondingto competing and changing priorities and multiple tasks under
inflexibletimelines.
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Requirements
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R E QU I R E D E D UC A TI O N A N D W O RK E X P E R I E N C E :
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Bachelor's Degree in Engineering or Life Sciences.
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Minimum 3 years of CQV and Fill Finish experience within GMP-regulated environments.
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Hands-on experience with vial filling equipment and processes.
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Strong understanding of cGMP requirements, data integrity, and validation lifecycle principles.
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Excellent technical writing, communication, project management, and stakeholder engagement skills.
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Exposure to ancillary Fill Finish systems including isolators, depyrogenation tunnels, sterile filtration systems, and related aseptic processing equipment.
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Ability to manage multiple project priorities while working directly with client and site teams.
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#J-*****-Ljbffr

📌 Cqv/Fill Finish Engineer - Melbourne (Victoria)
🏢 PSC Biotech
📍 Victoria