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 ResponsibilitiesCommission,
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.RequirementsRequired Qualifications & SkillsBachelor'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.Robust
working knowledge of FDA 21 CFR Parts *******, EU GMP Annex 1, and ISPE
baseline guides.

📌 Commissioning And Qualification (C&Q) Engineer (Melbourne)
🏢 PSC Biotech
📍 Melbourne