Project Engineer Melbourne

PSC Biotech; City of Melbourne; On-site; AUD 90,000 - 140,000; Full time

Job summary

PSC Biotech in Melbourne seeks a Project Engineer to drive capital engineering projects through design, procurement, installation, commissioning and qualification. You will ensure safe, on-time, on-budget delivery in line with GMP and regulatory standards.

Requirements include a Bachelor in Engineering or Science and 3 years’ experience in commissioning, qualification and validation within GMP/GxP environments, plus strong project management and CQV capabilities.

Qualifications

• Bachelor Degree in Engineering or Science required.
• Minimum 3 years’ experience in commission, qualify and validating facilities or capital projects within a GMP/GxP-regulated environment.
• Knowledge of project management principles, commissioning, qualification, and engineering systems.
• Experience with risk-based CQV approaches.
• Hands-on experience with FAT, SAT, IQ, OQ, and PQ activities.

Responsibilities

• Support and deliver capital engineering projects from concept through completion.
• Support delivery of project scope, schedules, and budgets to ensure successful outcomes.
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
• Assist in authors, revises, reviews, and completes controlled documents for CQV projects.
• Assist to review and qualify equipment for commissioning, qualification, and validation activities.
• Support GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on project activities and deliverables.
• Assist to initiate and coordinate risk analyses, design reviews, FAT/SAT, IQ, OQ, and PQ.

Skills

CQV

GMP

Capital projects

Project management

IQ/OQ/PQ

Risk management

Stakeholder comms

Education

Bachelor Degree in Engineering or Science

Job description

Melbourne, Australia | Posted on 08/17/2026

POSITIONSUMMARY

The Project Engineeris responsible for delivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualification. The role ensures projects are delivered safely, on time, within budget, and in compliance with applicable GMP and regulatory standards.

DUTIESANDRESPONSIBILITIES

• Support and deliver capital engineering projects from concept through completion.
• Support delivery of project scope, schedules, and budgets to ensure successful outcomes
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
• Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
• Assists to review and qualify equipment for commissioning, qualification, and validation activities.
• Supports to write and review GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on assigned project activities and deliverables.
• Assist to initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
• Assist with project scope, budget, schedule, and risk management.
• Coordinate engineering design, construction, commissionin g, and validation activities.
• Prepare technical specifications, project documentation, and procurement requirements.
• Ensure projects are delivered safely, compliantly, on time, and within budget.
• Support audits, inspections, and regulatory interactions asrequired
• Maintain clear, professional communication with all project stakeholders

DEMONSTRATEDCOMPETENCIES

• Business Development - Identifyand target potential clients. Work in a team environment; develop and execute a plan, in alignment with company vision, mission and strategic plans to engage potential customers.
• Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry and Internal team.
• Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus.
• Analytical Skills – Identifies, researches, anddemonstrateslogical reasoning to communicate critical information.
• Rational Persuasion – Presents key factors, influencing factors, and strategic goals toassiststakeholders inidentifyingsolutions.
• Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/ does affect people and their outcomes.
• Agility – Meetsobjectivesby responding to competing and changing priorities and multiple tasks under inflexible timelines.

Requirements

• Bachelor Degree in Engineering or Science.
• Minimum 3 years’ experience in commission, qualify and validating facilities or capital projects within a GMP/ GxP -regulated environment.
• Knowledge of project management principles, commissioning, qualification, and engineering systems.
• Experience with risk-based CQV approaches.
• Experience with packing line.
• Hands-on experience executing and facilitating FAT, SAT, IQ, OQ, and PQ activities.
• Understanding of quality systems, risk management, and contract administration.
• Strong stakeholder management, communication, and problem‑solving skills.