01 Oct
|
CS Executive Group
|
Melbourne
01 Oct
CS Executive Group
Melbourne
Engineering Manager – Pharmaceutical Manufacturing
ABOUT CHEMSKILL SCIENTIFIC & TECHNICAL RECRUITMENT
Since ****, 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
Robust 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 chance 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
#J-*****-Ljbffr
📌 Engineering Manager – Pharmaceutical Manufacturing (Melbourne)
🏢 CS Executive Group
📍 Melbourne