02 Oct
|
CS Executive Group
|
Melbourne
02 Oct
CS Executive Group
Melbourne
Job Description
Engineering Manager – Pharmaceutical Manufacturing n
ABOUT CHEMSKILL SCIENTIFIC & TECHNICAL RECRUITMENT
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Since ****, ChemSkill Scientific & Technical Recruitment has been one of Australia's longest-established specialist scientific and technical recruitment consultancies.
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We partner with organisations across the pharmaceutical, chemical, manufacturing, food, biotechnology and industrial sectors, recruiting for scientific, engineering, technical and quality-focused roles throughout Australia.
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With almost four decades of specialist experience, we provide permanent recruitment and contract/labour hire solutions, connecting talented people with outstanding career opportunities across Australia.
THE COMPANY n
CS Executive Group Inc. ChemSkill has been engaged to recruit an
Engineering Manager
for an established pharmaceutical manufacturer operating within a highly regulated GMP environment.
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Our client specialises in the development and manufacture of high-quality therapeutic products within a TGA-licensed facility. The business combines specialist pharmaceutical manufacturing expertise with a strong focus on quality, compliance, reliability and continuous improvement.
THE OPPORTUNITY n
This is a full-time senior, hands-on leadership prospect for an experienced Engineering Manager to take responsibility for the site's
engineering, maintenance, facilities, utilities, reliability, automation and capital project functions
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Reporting to the Manufacturing Manager, you will lead a multidisciplinary engineering and maintenance team and ensure that site equipment, facilities, utilities and engineering systems remain safe, reliable, compliant and capable of supporting uninterrupted manufacturing.
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Working closely with Manufacturing, Quality Assurance, Validation, Regulatory Affairs and HSE, you will play a key role in maintaining the site's validated state, supporting TGA inspection readiness and driving improvements across equipment reliability, infrastructure, compliance and operational performance.
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Key responsibilities will include:
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Lead the site's engineering, maintenance, facilities, utilities,
reliability and technical services functions
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Develop and execute engineering, maintenance and asset reliability strategies
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Lead preventive, corrective and predictive maintenance programs across manufacturing equipment and critical utilities
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Oversee cleanrooms, HVAC, purified water, compressed air, electrical infrastructure and other critical site systems
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Drive equipment reliability, plant uptime and asset lifecycle performance
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Lead capital projects, equipment installations, facility upgrades, automation and capacity improvement initiatives
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Manage projects from concept and business case through design, procurement, installation, commissioning, qualification and handover
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Support commissioning, qualification and validation activities including DQ, FAT, SAT, IQ, OQ and PQ
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Ensure engineering activities comply with TGA expectations, PIC/S GMP, Good Engineering Practice, WHS and site quality systems
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Manage engineering change controls, deviations, CAPAs and technical investigations
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Coordinate shutdowns, maintenance windows and facility works to minimise production disruption
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Manage engineering budgets, capital expenditure, contractors, service providers and project costs
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Lead, coach and develop engineering and maintenance personnel
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Drive continuous improvement across safety, compliance, reliability, productivity, energy efficiency and cost
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Represent Engineering during audits, regulatory inspections and site leadership meeting
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ABOUT YOU n
To be successful in this role, you will ideally have:
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A tertiary qualification in
Mechanical, Electrical, Chemical, Mechatronics, Process Engineering
or a related discipline
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Proven engineering leadership experience within pharmaceutical, therapeutic goods, medical device, FMCG, chemical or another highly regulated manufacturing environment
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Previous experience within a
GMP manufacturing environment
, ideally pharmaceutical or TGA regulated
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Strong experience leading maintenance, reliability, facilities, utilities and capital projects within a manufacturing site
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Working knowledge of
TGA requirements, PIC/S GMP, Good Engineering Practice, change control, deviations and CAPA
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Experience supporting equipment and facility commissioning, qualification and validation
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Experience with
DQ, IQ, OQ, PQ and equipment lifecycle documentation
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Strong understanding of preventive and predictive maintenance, root cause analysis and equipment reliability
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Experience using
CMMS or maintenance management systems
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Demonstrated experience managing contractors, engineering budgets and capital expenditure
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Strong people leadership skills with the ability to develop accountable, high-performing technical teams
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Excellent stakeholder management, communication and problem-solving capability
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Experience with pharmaceutical manufacturing equipment, cleanrooms, HVAC, purified water systems, compressed air, automation or other critical utilities will be highly regarded.
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Lean, Six Sigma, reliability engineering, project management qualifications or professional engineering registration would also be advantageous.
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BENEFITS n
This is an excellent opportunity to join an established manufacturing business in a highly influential site leadership position.
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You will have the opportunity to:
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Lead a broad and established engineering and maintenance function
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Work within a technically complex, highly regulated manufacturing environment
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Deliver significant capital, reliability and continuous improvement initiatives
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Partner closely with senior site leadership, Manufacturing and Quality
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Contribute directly to the reliability, compliance and long-term performance of the manufacturing facility
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#J-*****-Ljbffr
📌 Engineering Manager - Pharmaceutical Manufacturing (Melbourne)
🏢 CS Executive Group
📍 Melbourne