PSC Biotech® Corporation

Operational Readiness Engineer

PSC Biotech® Corporation  •  Melbourne, AU (Onsite)  •  23 hours ago
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Job Description


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


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.
PSC Biotech® Corporation

About PSC Biotech® Corporation

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. PSC Biotech Corporation 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 three unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, and BioTechnique™.

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.

To learn more, visit our website.

Industry
Biotech & Life Sciences
Company Size
501-1,000 employees
Headquarters
Pomona, CA
Year Founded
Unknown
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