Project Engineer

IDT Australia Limited; Melbourne; Vor Ort; AUD 90.000 - 130.000; Vollzeit

Zusammenfassung

IDT Australia in Boronia, Melbourne is seeking a Project Engineer to lead engineering projects, CQV activities and process improvements in a GMP environment. You will coordinate across Production, Quality and R&D teams from scoping through to handover, ensuring compliant, cost-effective outcomes.

The role emphasizes CQV execution, validation documentation and collaboration with internal stakeholders to enhance manufacturing capability, reliability and safety.

Qualifikationen

• Bachelor's degree in a relevant engineering discipline.
• Approximately 4 years' engineering experience in pharma or regulated manufacturing environments.
• Experience delivering engineering projects from planning and design through to commissioning and handover.
• Demonstrated CQV experience within GMP-regulated environments, including IQ/OQ/PQ protocols.

Aufgaben

• Coordinate engineering and capital projects from concept to commissioning and handover.
• Develop project scopes, URS, technical specifications, schedules, budgets and engineering documentation.
• Coordinate suppliers, contractors and internal stakeholders to deliver safe, compliant and cost-effective outcomes.
• Support process engineering activities, including manufacturing improvements, troubleshooting, trials and scale-up.
• Undertake commissioning, qualification and validation activities across equipment, facilities, utilities and related systems.
• Prepare, review and execute qualification protocols (DQ, IQ, OQ, PQ) and maintain validation documentation.
• Participate in engineering change controls, risk assessments and investigations.
• Identify opportunities to improve manufacturing efficiency, equipment performance, reliability and safety.
• Ensure engineering activities comply with GMP requirements, quality systems and safety obligations.

Kenntnisse

Project coordination

GMP knowledge

CQV experience

Communication skills

Problem-solving

Ausbildung

Bachelor's degree in Mechanical/Chemical/Process/Electrical Engineering

Jobbeschreibung

Engineering Projects | Pharmaceutical Manufacturing | Process Improvement & Validation

About IDT Australia

IDT Australia | Boronia, Melbourne VIC | Full-Time

Engineering Projects | Pharmaceutical Manufacturing | Process Improvement & Validation

About IDT Australia

IDT Australia is an Australian pharmaceutical contract development and manufacturing organisation (CDMO), providing specialist manufacturing solutions to local and international pharmaceutical companies.

Operating from our facility in Boronia, Victoria, we support the development and manufacture of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms within a highly regulated GMP environment.

As we continue to invest in our facilities, manufacturing capabilities and operational excellence, we are seeking a motivated and technically capable Project Engineer to join our Engineering team.

About the Role

Reporting to the Engineering Services Lead, this is an exciting opportunity for an engineer with approximately 4 years' relevant industry experience who enjoys a combination of engineering project delivery, process improvement and commissioning, qualification and validation (CQV).

You will support and coordinate engineering and capital projects across our pharmaceutical manufacturing facility, working closely with Production, Quality, R&D and other technical teams.

From initial project scoping and design through to equipment installation, commissioning, qualification and operational handover, you will play an important role in improving manufacturing capability, reliability, efficiency and compliance.

• Coordinate engineering and capital projects from concept and design through to commissioning and operational handover.
• Develop project scopes, User Requirement Specifications (URS), technical specifications, schedules, budgets and engineering documentation.
• Coordinate suppliers, contractors and internal stakeholders to deliver safe, compliant and cost-effective project outcomes.
• Support process engineering activities, including manufacturing improvements, technical troubleshooting, process trials and scale-up.
• Undertake commissioning, qualification and validation activities across manufacturing equipment, facilities, utilities and associated systems.
• Prepare, review and execute qualification protocols, including DQ, IQ, OQ and PQ, and maintain associated validation documentation.
• Participate in engineering change controls, risk assessments, investigations and technical problem-solving activities.
• Identify and implement opportunities to improve manufacturing efficiency, equipment performance, reliability and operational safety.
• Ensure engineering activities comply with GMP requirements, quality systems and workplace health and safety obligations.

About You

You are a practical, solutions-focused engineer who enjoys working across multiple technical projects and collaborating with operational and technical teams. You bring strong engineering fundamentals, sound technical judgement and a proactive approach to delivering outcomes.

Essential Qualifications & Experience

• Bachelor's degree in Mechanical, Chemical, Process, Electrical Engineering or a related engineering discipline.
• Approximately 4 years' relevant engineering experience within pharmaceutical, biotechnology, chemical processing or a comparable regulated manufacturing environment, with practical knowledge of GMP requirements.
• Demonstrated experience in engineering project delivery, involving manufacturing equipment, facilities, utilities or process improvements, from planning and design through to commissioning and operational handover.
• Demonstrated practical experience in commissioning, qualification and validation (CQV) within a GMP-regulated environment is essential, including preparing, reviewing or executing IQ, OQ and PQ protocols and associated technical documentation.
• Understanding of engineering change control, risk assessment, quality documentation and regulatory compliance requirements.
• Strong technical problem-solving, project coordination and organisational skills.
• Effective communication skills and the ability to work collaboratively with internal stakeholders, suppliers and contractors.

Highly Regarded

• Experience within pharmaceutical manufacturing, particularly API or Finished Dosage Form manufacturing.
• Experience with process development, manufacturing optimisation or scale-up activities.
• Familiarity with pharmaceutical facility utilities, HVAC, clean utilities or automated manufacturing equipment.
• Exposure to capital expenditure projects, engineering drawing systems or Lean manufacturing principles.

Why Join IDT Australia?

• Work on a diverse range of engineering and capital improvement projects within a specialist pharmaceutical manufacturing environment.
• Apply and further develop your expertise across project engineering, process optimisation and validation.
• Collaborate with experienced engineering, manufacturing, quality and technical professionals.
• Contribute directly to improvements in manufacturing capability, quality, reliability and operational performance.
• Be part of a collaborative team focused on continuous improvement, technical excellence and delivering results.

Interested?

If you are an enthusiastic engineer with a solid foundation in engineering project delivery and practical GMP validation experience, we would love to hear from you.