PSC Biotech Corporation

Operational Readiness Engineer

Posted Yesterday

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Melbourne, Victoria, AUS

In-Office

Junior

Biotech

The Role

Leads operational readiness for capital projects, transitioning facilities, utilities, equipment, and systems into routine operations. Responsibilities include design reviews, maintenance and reliability planning, CMMS/SAP setup, commissioning, qualification, validation, risk analyses, HAZOPs, FAT/SAT, IQ/OQ/PQ, documentation, training, and operational handover. The role coordinates engineering, project, maintenance, and operations stakeholders in a regulated manufacturing environment.

Summary Generated by Built In

POSITION SUMMARY:

The Operational Readiness Engineer is responsible for ensuring new facilities, equipment, and systems are effectively transitioned from project delivery into routine operations. Working closely with project, maintenance, and operations teams, the role supports commissioning, maintenance planning, asset readiness, documentation, training, and operational handover activities to ensure safe, compliant, and reliable operation of new assets within a regulated manufacturing environment.

Key Responsibilities

Lead engineering operational readiness activities for capital projects from design through operational handover.
Review engineering designs and develop maintenance, spare parts, and reliability strategies.
Coordinate CMMS/SAP data setup, preventive maintenance plans, and asset documentation.
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.
Collaborate with multiple departments on assigned project activities and deliverables.
Assist to initiate and coordinate risk analyses, design reviews, HAZOPs, execute FAT/SAT, IQ, OQ, and PQ.
Manage project handover, training, and knowledge transfer to Operations and Maintenance teams.

Requirements

Bachelor Degree in Engineering, Science, or a related discipline.

2+ years' experience in an engineering, maintenance, or project environment.

Strong understanding of maintenance strategies, reliability engineering, and asset lifecycle management.

Proven experience supporting project delivery, commissioning, and operational handover.

Excellent technical writing, documentation, stakeholder engagement, and project coordination skills.

Pharmaceutical or other GMP-regulated industry experience highly desirable.

Skills Required

Bachelor’s degree in Engineering, Science, or a related discipline
2+ years of experience in an engineering, maintenance, or project environment
Strong understanding of maintenance strategies, reliability engineering, and asset lifecycle management
Experience supporting project delivery, commissioning, and operational handover
Technical writing, documentation, stakeholder engagement, and project coordination skills
Pharmaceutical or other GMP-regulated industry experience

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The Company

HQ: Pomona, CA

445 Employees

Year Founded: 1996

What We Do

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.