Position Summary:

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

Key Responsibilities

- 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.

- Draft and 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 verify cleanroom laminar flow, containment, and FDA/EMA compliance.

- Inspect HVAC systems, perform HEPA filter integrity testing, and verify room pressure differentials.

- Author validation summary reports, manage change controls,



and investigate deviations per cGMP, Annex 1, and ISPE guidelines.

- Coordinate with Quality Assurance (QA), production, and third-party vendors to resolve field punch-list items.

Requirements

Required Qualifications & Skills

- Bachelor’s degree in Mechanical, Chemical, or Process Engineering, or a related discipline.

- Minimum of 3 to 5 years of hands-on validation or C&Q; experience within a cGMP/FDA-regulated pharmaceutical facility.

- Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

- Experience developing SOPS, final reports and validation & quality policies.

- Has good understanding and complies to cGMPs and CFR21.

- Strategic agility and action oriented with the ability to drive results.

- Technical Expertise:

- Direct experience executing and documenting cleanroom airflow visualization (smoke studies).

- Deep understanding of pharmaceutical HVAC systems, air handling units (AHUs), and pressure cascades.

- Ability to read and interpret P&IDs; and architectural drawings.

- Robust working knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 1, and ISPE baseline guides.

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