Pharma CQV Engineer: Cleanroom & HVAC Validation

PSC Biotech

Melbourne

On-site

AUD 90,000 - 130,000

Full time

2 days ago

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Job summary

PSC Biotech is seeking a Commissioning and Qualification (C&Q) Engineer in Melbourne, Australia to lead and support commissioning, qualification, and airflow visualization for pharmaceutical cleanrooms, isolators, and critical HVAC utilities to ensure regulatory compliance. The incumbent will execute CQV activities per cGMP, CFR 21, and ISPE guidelines.

Key responsibilities include drafting protocols (URS, DQ, IQ, OQ, PQ), validating facilities and equipment, and coordinating with QA,

Qualifications

Hands-on validation or CQV experience in a cgMP/FDA-regulated pharma facility.
Experience writing and reviewing CQV related documents and protocols.
Strong knowledge of cGMPs, CFR 21, and ISPE guidelines.

Responsibilities

Commission, qualify, and validate facilities, utilities, and equipment.
Assist in authoring, revising, and completing CQV controlled documents.
Review and qualify equipment for commissioning and qualification activities.
Draft and execute commissioning/qualification protocols (URS, DQ, IQ, OQ) for HVAC systems.
Plan and analyze airflow visualization studies to verify cleanroom performance.
Inspect HVAC systems, perform HEPA testing, verify pressure differentials.
Coordinate with QA, production, and vendors to close field punch-lists.