Melbourne, Australia | Posted on 08/17/2026

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 strong 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.

DU T I E S A N D R ES P O N SIBI L IT IE S :

- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
- Assists to review and qualify equipment for commissioning, qualification, and validation activities.
- Supports to write and review GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Assist to initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
- Ensure system integration with filling lines and compliance with validation requirements.
- Support MES recipe startup , debugging, and documentation updates to align with process optimization efforts.
- Collaborate with client teams, vendors, contractors, and cross-functional stakeholders to deliver project objectives.
- Manage project activities, timelines, and status reporting while ensuring compliance with cGMP and data integrity requirements.

DEMO N S TR A T E D C O M P E T E N CI ES :





- 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.
- 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.
- Negotiation Skills -Active listening, needs assessment, and presents visions to build a consensus.
- Analytical Skills -Identifies, researches, and demonstrates logical reasoning to communicatecritical information.
- Rational Persuasion -Presents key factors, influencing factors, and strategic goals to assiststakeholders in identifying solutions.
- Interpersonal Awareness - Ability to be aware of how actions, ideas, and communicationcan/does affect people and their outcomes.
- Agility - Meets objectives by respondingto competing and changing priorities and multiple tasks under inflexibletimelines.

Requirements

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 :

- Bachelor's Degree in Engineering or Life Sciences.

- Minimum 3 years of CQV and Fill Finish experience within GMP-regulated environments.

- Hands-on experience with vial filling equipment and processes.

- Solid understanding of cGMP requirements, data integrity, and validation lifecycle principles.

- Excellent technical writing, communication, project management, and stakeholder engagement skills.

- Exposure to ancillary Fill Finish systems including isolators, depyrogenation tunnels, sterile filtration systems, and related aseptic processing equipment.

- Ability to manage multiple project priorities while working directly with client and site teams.

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📌 CQV/Fill Finish Engineer - Melbourne
🏢 PSC Biotech
📍 Melbourne