Commissioning and Qualification (C&Q;) Engineer

Melbourne, Australia | Posted on 10/21/2026

The Commissioning and Qualification (C&Q;) Engineer will lead and support the planning, execution, and documentation ofcommissioning, qualification, and airflow visualization (smoke studies) for pharmaceutical cleanrooms, isolators, and critical HVAC utilities to ensurestrict regulatory compliance. The incumbent is also responsible and accountablefor the execution of the PSC mission, “to maintain the integrity andprofessionalism of our products and services while enabling steady growth anddevelopment”.

Key Responsibilities

- Commission,qualify, and validate facilities, utilities, and/or equipment in assignedprojects.

- Assists in authors, revises, reviews, and completes controlled documentsfor CQV projects.

- Assists to review and qualify equipment for commissioning,qualification, and validation activities.

- Draftand execute commissioning and qualification protocols (URS, DQ, IQ, OQ)for pharmaceutical HVAC systems and critical manufacturing utilities.

- Plan,record, and analyze airflow visualization studies to verifycleanroom laminar flow, containment, and FDA/EMA compliance.
- InspectHVAC systems, perform HEPA filter integrity testing, and verify roompressure differentials.




- Authorvalidation summary reports, manage change controls, and investigatedeviations per cGMP, Annex 1, and ISPE guidelines.
- Coordinatewith Quality Assurance (QA), production, and third-party vendors toresolve field punch-list items.

Requirements

Required Qualifications & Skills

- Bachelor’sdegree in Mechanical, Chemical, or Process Engineering, or a relateddiscipline.
- Minimumof 3 to 5 years of hands-on validation or C&Q; experience withina cGMP/FDA-regulated pharmaceutical facility.
- Experienceauthoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

- Experience developing SOPS, final reports and validation & qualitypolicies.

- Has valuable understanding and complies to cGMPs and CFR21.
- Strategic agility and action oriented with the ability to drive results.

- TechnicalExpertise:
- Directexperience executing and documenting cleanroom airflow visualization(smoke studies).
- Deepunderstanding of pharmaceutical HVAC systems, air handling units (AHUs),and pressure cascades.
- Abilityto read and interpret P&IDs; and architectural drawings.
- Strongworking knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 1, and ISPEbaseline guides.

#J-18808-Ljbffr

📌 Commissioning and Qualification (C&Q) Engineer (Melbourne)
🏢 PSC Biotech
📍 Melbourne