Commissioning and Qualification (C&Q) Engineer

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 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.

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