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.
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.
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