Job Description

Engineering Manager – Pharmaceutical Manufacturing n

ABOUT CHEMSKILL SCIENTIFIC & TECHNICAL RECRUITMENT

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Since 1988, 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 opportunity 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, Valuable 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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📌 Engineering Manager - Pharmaceutical Manufacturing (Melbourne)
🏢 CS Executive Group
📍 Melbourne