CQV Project Engineer - GMP Capital Projects

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

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.