Senior Principal Engineer Facilities, Clinical Trial Distribution

Role Summary

The Facilities Engineer for our Clinical Trial Distribution facility (K401) directs and supervises a small but growing team for all engineering, technical process improvements, warehouse maintenance, HSE, and security activities required to support facility operations, maintain stabilization, and promote optimization. The role is responsible for maintaining required GMP temperature data and monitoring systems that are auditable by external agencies. They lead and oversee K401’s required technical building upgrades and repairs, plus a $15M technology modernization project, including AS/RS upgrades and process automation. The Facility Engineer chairs the local Safety Committee and serves on the Clinical Supply and Delivery Safety Committee, fostering a strong safety culture. The role emphasizes cross-functional relationship building and developing a network of outside service providers to support facility needs.

Responsibilities

• Lead and manage all facility related Engineering, Maintenance, Security & HSE activities at Building K401
• Supervise a technical team of engineers and technicians for warehouse upgrades and repair projects that drive process improvements
• Support regulatory and HSE audits with facility and temperature data
• Ensure compliant temperature measurement, monitoring, and data storage for clinical trial material
• Develop, refine, and implement complex strategic and operational decisions
• Influence regulatory, business and technical issues at Building K401
• Anticipate and resolve key technical, operational and business challenges
• Manage resources and departmental budget while evaluating workload and service providers
• Drive Engineering, Maintenance, Security & HSE solutions for K401 operations
• Lead and execute large-scale projects with inherent risk and resource constraints
• Manage budgets for capital projects and ongoing operations
• Build and leverage relationships with internal and external partners to benefit facility operations
• Interact with regulators and stakeholders to represent K401 Engineering, Maintenance, and Security & HSE
• Develop and maintain facility Business Continuity Plan (BCP)
• Ensure compliant K401 Pest Management Coordination
• K401 Building Security Warden
• Operational owner of Periodic Quality Evaluation for Building K401
• Collaborate closely with operational teams requiring intimate knowledge of procedures and processes

Qualifications

• Required: BS in Mechanical, Chemical, or other engineering
• Required: 8 years’ experience and proven success managing facility engineering, leading technical process improvement projects, maintenance, security & HSE operations
• Required: Specialized depth and breadth of knowledge in Engineering, Maintenance, Security & HSE
• Required: Strong organizing/multi-tasking skills
• Required: Excellent interpersonal and networking skills
• Required: Strong written and verbal communication skills
• Required: Ability to work well in a team environment
• Required: Strong computer skills
• Required: Must speak fluent English
• Preferred: Capital project management experience (start-up and process improvement)
• Preferred: Project Management Professional (PMP) certification
• Preferred: Working knowledge of cGMP’s, cGDP’s and cold-chain
• Preferred: Experience with GMP facility commissioning and qualification
• Preferred: Technical knowledge of building systems (HVAC, refrigeration, chilled water, generators, etc.)
• Preferred: Lean and Six Sigma concepts
• Preferred: Experience with SMART Metrics and Scorecards
• Preferred: Experience with critical IT systems (Engineering Document Management, Maintenance Management, Change/Deviation Management)
• Preferred: Familiarity with building management systems

Skills

• Interpersonal and networking skills
• Written and verbal communication
• Team collaboration and cross-functional liaison
• Problem solving and strategic decision making
• Technical aptitude across facility systems and operations

Education

• BS in Mechanical, Chemical, or related engineering field

Additional Requirements

• Requires 24/7 on-call availability for facility maintenance and engineering emergencies
• In office position
• Minimal travel may be required, both domestic and international
• After hiring, apply for, pass an exam, and gain approval for TSA warehouse access