CQV Engineer: Cleanroom & HVAC Validation Expert

PSC Biotech® Corporation; Melbourne; On-site; AUD 110,000 - 160,000; Full time

Job summary

The Commissioning and Qualification (C&Q) Engineer at PSC Biotech Corporation will lead and support the planning, execution, and documentation of CQV activities for pharmaceutical cleanrooms, HVAC systems, and associated utilities, ensuring compliance with cGMP and regulatory standards.

You will collaborate with QA, production, and vendors to generate validated documentation, perform airflow visualization (smoke studies), and manage change controls while driving project delivery in Melbourne.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, or Process Engineering.
• 3–5 years hands-on validation or CQV in a cGMP/FDA-regulated pharma facility.
• Experience drafting DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Experience developing SOPs, final reports and validation/quality policies.
• Strong understanding of cGMPs and CFR21 requirements.
• Ability to read P&IDs and architectural drawings.

Responsibilities

• Commission, qualify, and validate facilities, utilities, and/or equipment in projects.
• Assist in authoring, revising, reviewing, and completing controlled CQV documents.
• Assist reviewing and qualifying equipment for CQV activities.
• Draft and execute commissioning and qualification protocols (URS, DQ, IQ, OQ) for HVAC systems.
• Plan and analyze airflow visualization studies to verify cleanroom laminar flow and compliance.
• Inspect HVAC systems, perform HEPA integrity testing, and verify room pressures.
• Author validation summary reports, manage change controls, and investigate deviations.
• Coordinate with QA, production, and vendors to resolve punch-list items.

Skills

CQV validation experience

cGMP/FDA knowledge

DQ/IQ/OQ/PQ/PV expertise

Airflow visualization (smoke studies)

P&IDs reading

ISPE guidelines knowledge

Education

Bachelor’s degree in Mechanical, Chemical, or Process Engineering

Job description

The Commissioning and Qualification (C&Q) Engineer at PSC Biotech Corporation will lead and support the planning, execution, and documentation of CQV activities for pharmaceutical cleanrooms, HVAC systems, and associated utilities, ensuring compliance with cGMP and regulatory standards.

You will collaborate with QA, production, and vendors to generate validated documentation, perform airflow visualization (smoke studies), and manage change controls while driving project delivery in Melbourne.