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Tech Observer is seeking a Facilities Project Engineer to lead clean room and equipment upgrade projects in a GMP-regulated facility. You will coordinate procurement, installation, and validation activities while ensuring minimal disruption to operations.
Role requires at least 5 years in facilities management, familiarity with BSC/BSCE, LFG, and clean rooms, and strong collaboration with C&Q teams and external vendors. On-site work across multiple phases is expected.
We are seeking a highly organized and experienced Facilities Project Engineer to lead the execution of clean rooms and equipment upgrade projects. This role will focus on supporting the facility improvement plan, with a strong emphasis on project coordination, vendor management, and technical oversight in a GMP-regulated environment.
Develop detailed project schedules and roadmaps for equipment procurement and installation.
Identify and document nuanced requirements for clean room upgrades and equipment replacement.
Lead execution of upgrades, including biosafety cabinet (BSE) replacements, laminar flow glove box (LFG) installations, and particle monitoring system enhancements.
Coordinate shutdowns and modifications of specific units, including after-hours and early morning work as needed (e.g., 12 AM–6 AM shifts during implementation).
Oversee upgrades to active air monitoring systems and viable particle identification processes.
Manage Siemens EMS work and integration with automation systems.
Supervise installation of 8 BSEs and 9 LFGs across multiple phases.
Coordinate upgrades to camera systems, sprinkler systems, HVAC, and air handling units.
Work closely with Commissioning & Qualification (C&Q) teams to ensure compliance and validation.
Gather input from various stakeholders to develop comprehensive qualification plans.
Serve as the primary liaison with vendors and contractors.
Plan and manage execution timelines, ensuring minimal disruption to operations.
Minimum 5 years of experience in Facilities Management, supporting GMP-regulated environments, including BSC/BSCE (Biosafety Cabinets), LFG (Laminar Flow Glove Boxes), and Grade A/B/C Clean Rooms.
Bachelor’s degree in Engineering, Architecture, or a related technical discipline.