Engineering Manager – Pharmaceutical Manufacturing

CS Executive Group; City of Melbourne; On-site; AUD 180,000 - 240,000; Full time

Job summary

CS Executive Group is seeking an Engineering Manager for a pharmaceutical manufacturing site in Melbourne. You will lead engineering, maintenance, facilities, utilities, reliability and capital projects to ensure safe, compliant operations and uninterrupted production.

You will work with Manufacturing, QA, Validation, Regulatory, and HSE to maintain validated state, drive reliability improvements, and lead a multidisciplinary team in a highly regulated GMP environment.

Qualifications

• Bachelor or higher degree in a relevant engineering discipline.
• Proven engineering leadership in regulated manufacturing (pharma, GMP, or TEV).
• Experience with GMP/TGA environments and capital projects.
• Experience with CMMS or maintenance management systems.

Responsibilities

• Lead engineering, maintenance, facilities, utilities, reliability and technical services functions.
• Develop and execute asset reliability and maintenance strategies.
• Oversee capital projects, automation and capacity improvements.
• Coordinate commissioning, qualification and validation activities (DQ/IQ/OQ/PQ).
• Drive safety, compliance and continuous improvement across site engineering.

Skills

Leadership

Stakeholder management

Problem solving

Team development

Education

Mechanical, Electrical, Chemical, Mechatronics, Process Engineering

Tools

CMMS

Job description

Engineering Manager – Pharmaceutical Manufacturing

ABOUT CHEMSKILL SCIENTIFIC & TECHNICAL RECRUITMENT

Since 1988, ChemSkill Scientific & Technical Recruitment has been one of Australia's longest-established specialist scientific and technical recruitment consultancies.

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.

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

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.

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

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.

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.

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.

Key responsibilities will include:

• Lead the site's engineering, maintenance, facilities, utilities, reliability and technical services functions
• Develop and execute engineering, maintenance and asset reliability strategies
• Lead preventive, corrective and predictive maintenance programs across manufacturing equipment and critical utilities
• Oversee cleanrooms, HVAC, purified water, compressed air, electrical infrastructure and other critical site systems
• Drive equipment reliability, plant uptime and asset lifecycle performance
• Lead capital projects, equipment installations, facility upgrades, automation and capacity improvement initiatives
• Manage projects from concept and business case through design, procurement, installation, commissioning, qualification and handover
• Support commissioning, qualification and validation activities including DQ, FAT, SAT, IQ, OQ and PQ
• Ensure engineering activities comply with TGA expectations, PIC/S GMP, Good Engineering Practice, WHS and site quality systems
• Manage engineering change controls, deviations, CAPAs and technical investigations
• Coordinate shutdowns, maintenance windows and facility works to minimise production disruption
• Manage engineering budgets, capital expenditure, contractors, service providers and project costs
• Lead, coach and develop engineering and maintenance personnel
• Drive continuous improvement across safety, compliance, reliability, productivity, energy efficiency and cost
• Represent Engineering during audits, regulatory inspections and site leadership meeting

ABOUT YOU

To be successful in this role, you will ideally have:

• A tertiary qualification in Mechanical, Electrical, Chemical, Mechatronics, Process Engineering or a related discipline
• Proven engineering leadership experience within pharmaceutical, therapeutic goods, medical device, FMCG, chemical or another highly regulated manufacturing environment
• Previous experience within a GMP manufacturing environment, ideally pharmaceutical or TGA regulated
• Strong experience leading maintenance, reliability, facilities, utilities and capital projects within a manufacturing site
• Working knowledge of TGA requirements, PIC/S GMP, Good Engineering Practice, change control, deviations and CAPA
• Experience supporting equipment and facility commissioning, qualification and validation
• Experience with DQ, IQ, OQ, PQ and equipment lifecycle documentation
• Strong understanding of preventive and predictive maintenance, root cause analysis and equipment reliability
• Experience using CMMS or maintenance management systems
• Demonstrated experience managing contractors, engineering budgets and capital expenditure
• Strong people leadership skills with the ability to develop accountable, high-performing technical teams
• Excellent stakeholder management, communication and problem-solving capability
• Experience with pharmaceutical manufacturing equipment, cleanrooms, HVAC, purified water systems, compressed air, automation or other critical utilities will be highly regarded.
• Lean, Six Sigma, reliability engineering, project management qualifications or professional engineering registration would also be advantageous.

BENEFITS

This is an excellent opportunity to join an established manufacturing business in a highly influential site leadership position.

You will have the opportunity to:

• Lead a broad and established engineering and maintenance function
• Work within a technically complex, highly regulated manufacturing environment
• Deliver significant capital, reliability and continuous improvement initiatives
• Partner closely with senior site leadership, Manufacturing and Quality
• Contribute directly to the reliability, compliance and long-term performance of the manufacturing facility