Equipment Project Engineer - Automation
Purpose
Responsible for delivering automation and equipment upgrade projects within a regulated biopharmaceutical environment. This includes ownership of multiple Lyo, CLU, PMS, Autoclave, and control‐system upgrade packages across several phases. The engineer will coordinate OEMs, ITS, Automation, Validation, and Quality teams to ensure compliant, right‐first‐time execution.
Responsibilities
General Project Delivery
- Manage end‐to‐end delivery of automation and equipment upgrade projects (schedule, cost, scope, safety, quality, compliance).
- Coordinate OEMs, ITS, Automation, Validation, and Quality for multi‐phase deployments.
- Lead FAT/SAT activities, documentation, change controls, and qualification support.
- Ensure servers, control systems, and infrastructure are prepared, validated, and deployed correctly.
- Track change control actions to closure and maintain project governance.
- Manage line time, shutdown planning, and deployment coordination.
- Provide weekly progress updates to stakeholders.
Automation & Lyo‐Related Project Packages (Shortened)
The role will support multiple automation and equipment upgrade projects across Lyo, CLU, PMS, Autoclave, and control‐system platforms. Key responsibilities include coordinating OEMs, ITS, Automation, Validation, and Quality teams; managing multi‐phase deployments; ensuring servers and control systems are prepared and validated; supporting FAT/SAT activities; and tracking change controls to closure.
Required Skills & Experience
- Degree in Process, Mechanical, Chemical, Industrial, or related Engineering discipline.
- 5+ years' experience delivering automation or equipment projects in pharmaceutical/biotech GMP environments.
- Strong understanding of GMP/GDP, validation lifecycle, cleanroom standards, and aseptic processing.
- Experience with OEM coordination, server upgrades, control‐system deployments, and CQV activities.
- Strong project planning, scheduling, budgeting, and risk management skills.
- Ability to manage multi‐phase, multi‐stakeholder projects.
- Proficiency in MS Office and project management tools.
