POSITION
SUMMARY
:
The Project Engineer
is 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.
DUTIES
AND
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.
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 as required
Maintain clear, professional communication with all project stakeholders
DEMONSTRATED
COMPETENCIES:
Business Development -
Identify




and 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, and
demonstrates
logical reasoning to communicate critical information.
Rational Persuasion
– Presents key factors, influencing factors, and strategic goals to
assist
stakeholders in
identifying
solutions.
Interpersonal Awareness
– Ability to be aware of how actions, ideas, and communication can/
does
affect people and their outcomes.
Agility
– Meets
objectives
by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
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.
Robust stakeholder management, communication, and problem-solving skills.

📌 Project Engineer Melbourne
🏢 PSC Biotech
📍 Melbourne