20 Sep
|
PSC Biotech
|
Victoria
20 Sep
PSC Biotech
Victoria
Job Description
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We are looking for a
Process Engineer - Utilities
to join our team on a
12-month contract.
Work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape.
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The role is also responsible and accountable for supporting the PSC mission: "to maintain the integrity and professionalism of our products and services while enabling steady growth and development."
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Key Duties and Responsibilities
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Support process engineering activities for new, modified, and existing utility and manufacturing systems across the project lifecycle.
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Support the design, installation, startup, commissioning, qualification, and optimisation of utility systems and associated process equipment.
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Prepare, review, revise, and complete controlled engineering and CQV documentation, including specifications, drawings, risk assessments, test protocols, reports, procedures, and turnover records.
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Execute and document DQ, FAT, SAT, IQ, OQ, PQ, and other commissioning or validation activities, as applicable to the assigned systems and project scope.
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Perform field verification, system walkdowns, inspections, testing, troubleshooting, and readiness checks for utilities, equipment, instruments, controls, and interfaces.
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Assess utility capacity, performance, reliability, and compliance against process requirements, user requirements, design intent, and operational needs.
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Support process startup and the introduction of new or modified equipment and systems into GMP operations.
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Provide process engineering input into technical specifications, equipment selection, P&IDs;, layouts, control strategies, operating parameters, and system boundaries.
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Assist with technology transfer, process scale-up, equipment readiness, and the development or revision of SOPs and operating documentation.
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Troubleshoot process and utility issues, identify root causes, and recommend practical improvements that strengthen safety, compliance, reliability, and performance.
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Collaborate with client teams, quality, operations, maintenance, automation, vendors, and contractors to deliver project milestones and resolve technical issues.
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Provide clear progress updates, escalate risks or constraints promptly, and complete assigned deliverables within agreed timelines.
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Work safely and comply with PSC and client policies, procedures, permit requirements, and site safety expectations.
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Additional duties and responsibilities may be assigned from time to time.
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Utilities Experience
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Experience supporting one or more of the following is desirable, depending on the project scope:
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Clean and process
utilities
, such as purified
water
, water for injection, clean
steam
, process gases, compressed
air
, and clean-in-place systems.
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Plant utilities,
such as
HVAC
,
chilled water, cooling water, glycol, steam, condensate, electrical interfaces, and waste systems.
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Process equipment, including vessels, pumps, valves, heat exchangers, piping, instrumentation, automated skids, and associated control systems.
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Aseptic, controlled, or highly automated manufacturing environments.
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nRequirements n
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Bachelor Degree in Engineering, Science, or a related discipline.
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At least 2 years of relevant engineering experience within pharmaceutical, biotechnology, medical device, or another regulated GMP workplace.
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Practical experience supporting process development, utilities, equipment startup, commissioning, qualification, validation, or manufacturing operations.
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Experience preparing, reviewing, or executing engineering and CQV documentation, such as specifications, risk assessments, FAT, SAT, IQ, OQ, PQ, protocols, and reports.
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Working knowledge of GMP, GDP, data integrity, quality systems, and regulated project delivery expectations.
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Ability to read and interpret technical drawings, P&IDs;, specifications, manuals, and vendor documentation.
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Strong analytical, troubleshooting, organisation, and written communication skills.
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Ability to work collaboratively across disciplines and manage competing priorities in a project environment.
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📌 Process Engineer - Utilities (Victoria)
🏢 PSC Biotech
📍 Victoria