At a Glance
- Tasks: Lead and support commissioning and qualification for pharmaceutical cleanrooms and HVAC systems.
- Company: Join a leading pharmaceutical company committed to integrity and growth.
- Benefits: Competitive salary, professional development, and a dynamic work environment.
- Other info: Exciting opportunities for career advancement in a fast-paced industry.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring regulatory compliance.
- Qualifications: Bachelor’s degree in Engineering and 3-5 years of C&Q experience required.
The predicted salary is between 92475 - 113025 $ per year.
- 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.
- Inspect HVAC systems, perform HEPA filter integrity testing, and verify roompressure differentials.
- Authorvalidation summary reports, manage change controls, and investigatedeviations per c GMP, 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 c GMP/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 c GMPs and CFR21.
- Strategic agility and action oriented with the ability to drive results.
- Technical
Expertise
- 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.
- #J-18808-Ljbffr
Commissioning and Qualification (C&Q) Engineer in Melbourne employer: PSC Biotech
As a Senior Process Engineer in Melbourne, you'll join a dynamic team dedicated to innovation in the pharmaceutical sector. Our company fosters a collaborative work culture that prioritises employee growth through continuous learning and development opportunities, while also offering competitive benefits and a commitment to compliance and quality. With a focus on operational excellence and cutting-edge technology, we provide a rewarding environment where your expertise will directly contribute to impactful projects.
