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
* Lead and deliver capital engineering projects from concept through to completion.
* Manage project scope, schedules, and budgets to ensure successful outcomes.
* Coordinate equipment installation, commissioning, and qualification activities.
* Monitor project progress and provide clear, regular updates to key stakeholders.
* Support equipment procurement and manage vendor and contractor engagement.
* Review quotations and cost estimates, contributing to value‐engineering initiatives.
* Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as required.
* Oversee onsite installation and commissioning activities at client or project sites.
* Support equipment qualification activities, including IQ, OQ, and PQ.
* Prepare and maintain project and qualification documentation in line with regulatory standards.
* Ensure all project activities and documentation comply with GMP, TGA, FDA, and GxP requirements.
* Partner closely with Quality and Validation teams throughout the project lifecycle.
* Support audits, inspections, and regulatory interactions as required.
* Work collaboratively with internal teams and external vendors to deliver project outcomes.
* Coordinate across engineering, quality, procurement, and operations functions.
* Maintain clear, professional communication with all project stakeholders.
Demonstrated Competencies
* Business Development – Identify and target potential clients, develop and execute a plan aligned with company vision and mission.
* Relationship Building – Build long‐term partnerships across formal and informal networks in the life science industry.
* Negotiation Skills – Active listening, needs assessment, and presenting visions to build consensus.
* Analytical Skills – Research and logical reasoning to communicate critical information.
* Rational Persuasion – Present key factors and strategic goals to assist stakeholders in identifying solutions.
* Interpersonal Awareness – Awareness of how actions, ideas, and communication affect people and outcomes.
* Agility – Meet objectives by responding to competing priorities under inflexible timelines.
Requirements
* Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, or related discipline).
* 3+ years experience delivering engineering projects in a regulated environment.
* Understanding of GMP and regulated industry requirements.
* Experience supporting equipment installation, commissioning, and qualification activities.
* Background in pharmaceutical, biotech, medical device, or similar regulated industries (preferred).
* Strong organisational, communication, and stakeholder coordination skills.
* Ability to manage multiple tasks and priorities effectively.
* Exposure to project management and validation practices is desirable.
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