About the Role We are seeking Process Engineers to support ongoing process development and manufacturing scale‑up activities within a GMP‑regulated environment. This role will play a key part in ensuring production readi…
Skills: Process Development, GMP Compliance, Equipment Commissioning, Aseptic Processing, Tech Transfer
POSITION SUMMARY: We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract.The Senior CQV Engineer is responsible for ensuring systems, facilities, a…
POSITION SUMMARY: We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract.The Senior CQV Engineer is responsible for ensuring systems, facilities, a…
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Contract
bachelor degree
Posted 70d ago
~40 hrs/week
Responsibilities
Lead process development and the commissioning of manufacturing equipment within a GMP-regulated environment. Support tech transfer activities and optimize automated systems to ensure a smooth transition to commercial operations.
Requirements
Requires a Bachelor's degree in Engineering and at least 2 years of experience in GMP-regulated industries such as pharma or biotech. Candidates must have proven experience in process startup and aseptic processing.
Full job description
About the Role
We are seekingProcess Engineersto support ongoing process development and manufacturing scale‑up activities within aGMP‑regulated environment. This role will play a key part in ensuring production readiness by supporting the startup of new manufacturing equipment,optimisingexisting processes, and enabling a smooth transition to commercial operations.
The successful candidates will bringhands‑on experiencein equipment and process startup, with exposure toaseptic and automated systemswithinmedicaldevice, biotechnology, or pharmaceuticalenvironments.
This position is available as:
One 12‑month contract
One 6‑month contract
Both roles offer the opportunity to work on critical manufacturing and process development initiatives in a regulated setting.
Key Responsibilities
Lead and supportprocess development activitiesfor new and existing manufacturing processes.
Execute and documentstartup, commissioning, andoptimisationof manufacturing lines and equipment for GMP use.
Collaborate with cross-functional teams to ensure processes are compliant withGMP standardsand meet operational needs.
Assistwithtech transferactivities, including drafting and reviewing process documentation and procedures.
Support the development and implementation ofautomation processeswithin aseptic or controlled production environments.
Troubleshoot process issues and contribute to continuous improvement initiatives.
Work closely with site engineering, operations, and quality teams to ensure delivery of project milestones.
Provide input into process risk assessments, validation activities, and equipment readiness.
Requirements
Required Qualifications & Experience
Bachelor’s degree in Engineering(Chemical, Mechanical, Biomedical, Process Engineering, or related discipline).
2 +years experienceinmedicaldevice,biotech,pharmaceutical,or similar regulated GMP industries.
Proven experience inprocess developmentwithin a GMP manufacturing environment.
Demonstrated experiencestarting up or bringing online manufacturing equipment or processesfor GMP operations.
Strong understanding of GMP, quality systems, and regulated industry expectations.
Experience inaseptic processingand/or development ofautomated manufacturing lines.
Excellent problem-solving skills and ability to work independently in a fast-paced environment.
Preferred Experiance
Previoustech transferexperience within a GMP setting.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers.
To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
EQMSenterprise quality management softwareauditinginspectionsregulatory compliancedocument management21 CFR Part 11workflow managementcloud-basedhosted
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