Commissioning and Qualification (C&Q) Engineer

PSC Biotech; Melbourne; On-site; AUD 90,000 - 130,000; Full time

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.

Skills

CQV experience

Regulatory compliance

Document authoring

cGMP compliance

Education

Bachelors in Mechanical/Chemical/Process Eng

Job description

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 good 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.