Facilities Engineer

Our Work MattersAt Kindeva we make products that improve peoples lives. Every day our teams develop and manufacture pharmaceutical therapies and medical devices that patients worldwide depend KindevaPurpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation At Kindeva were more than a global Contract Development and Manufacturing Organization (CDMO). Were a team dedicated to improving patient outcomes through innovation collaboration and operational looking for a Facilities Engineer to provide facilities and utilities engineering support for our Lexington pharmaceutical manufacturing site. This individual contributor role will lead facility and infrastructure projects coordinate contractors and external engineering partners support site maintenance activities and help ensure our facility and utility infrastructure supports both current operations and future site Impact You Will MakeAs a Facilities Engineer you will serve as a key technical resource connecting Engineering Operations Maintenance Quality Validation EHS contractors and external engineering service will manage multiple projects and contractors while supporting facility systems including HVAC electrical distribution plumbing utilities cleanrooms building automation and other manufacturing-support infrastructure. You will help ensure work is completed safely efficiently cost-effectively and in accordance with cGMP requirements and applicable codes and will also play an important role in long-range facility and space planning helping Kindeva evaluate infrastructure needs and prepare the Lexington site for future is an individual contributor position with project and contractor leadership responsibilities and no direct & Capital Project ManagementLead facility infrastructure and site improvement projects from scope development through execution completion and turnover. Develop project scopes schedules preliminary budgets estimates execution plans and capital expenditure requests or business cases. Coordinate engineering procurement construction installation commissioning and project closeout activities. Manage multiple projects and priorities while monitoring project schedules costs risks and overall performance. Review contractor proposals estimates schedules drawings specifications and statements of work. Coordinate projects with Manufacturing Quality Validation Maintenance EHS IT/Automation and other site functions. Identify project risks and develop practical mitigation strategies. Ensure completed projects are properly documented transferred to the appropriate site functions and incorporated into asset and maintenance programs. Contractor & Service Provider ManagementServe as a primary site engineering contact for contractors and external service providers supporting facilities utilities maintenance construction and capital projects. Develop scopes of work obtain and evaluate quotations and assess contractor capabilities technical proposals schedules and pricing. Coordinate contracted maintenance activities including preventive predictive corrective and specialty maintenance services. Coordinate contractor access scheduling work permits shutdowns escorts and other site requirements. Monitor contractor performance for safety quality schedule cost workmanship GMP compliance and documentation. Verify completed work and required documentation prior to project closeout or authorization of payment. Ensure contractors comply with site procedures safety requirements cGMP expectations and Good Documentation Practices. Coordinate contractor activities to minimize disruption to manufacturing and laboratory operations. Facilities & Utilities EngineeringProvide technical support for facility and utility systems including HVAC and environmental controls cleanrooms electrical distribution and emergency power plumbing domestic/process water compressed air and process gases chilled water and heating systems building automation and monitoring systems fire protection/life-safety systems drainage and other manufacturing-support utilities. Develop a practical understanding of system design operation capacity criticality and maintenance requirements. Review P&IDs electrical drawings HVAC schematics equipment specifications architectural drawings and construction documents. Support troubleshooting and technical investigations involving facility and utility systems. Identify infrastructure constraints and capacity limitations that could affect manufacturing or future expansion. Support utility shutdown planning and execution. Evaluate facility and utility requirements associated with new equipment process changes technology transfers equipment relocations and manufacturing expansions. GMP Qualification & Change ControlEnsure facility and engineering projects are executed in accordance with applicable cGMP requirements site procedures and approved project controls. Participate in change controls deviations CAPAs investigations and risk assessments involving facilities utilities equipment and projects. Partner with Quality and Validation on commissioning qualification and validation requirements for new or modified systems. Support the development and review of URSs design specifications commissioning and qualification documentation and turnover packages. Participate in FAT/SAT commissioning system walkdowns punch-list development and project acceptance activities as appropriate. Ensure engineering changes and project records are appropriately documented and maintained in an inspection-ready state. Support regulatory inspections and customer audits as a facilities/engineering technical resource. Facility Planning Asset Lifecycle & Maintenance SupportMaintain and support current and future-state facility and space utilization plans in coordination with Operations and site leadership. Evaluate space and infrastructure requirements for manufacturing laboratories warehousing offices utilities maintenance and other support functions. Assess facility and utility impacts associated with equipment installations relocations process changes and expansion projects. Identify opportunities to improve utilization of existing space and infrastructure and support long-range site planning. Maintain or coordinate facility drawings equipment layouts utility plans and related engineering records. Partner with Maintenance and Operations to identify facility and equipment reliability improvements. Support preventive maintenance strategies equipment lifecycle planning and replacement or refurbishment needs. Support CMMS asset documentation work-order development preventive maintenance requirements and asset criticality assessments. Support technical specifications spare-parts strategies and service-contract strategies for critical facility assets. Safety & ComplianceEnsure project and contractor activities are conducted in accordance with applicable EHS requirements. Participate in contractor safety reviews and applicable work controls including job hazard analyses lockout/tagout confined-space requirements and hot-work controls. Ensure facility modifications comply with applicable building electrical fire mechanical environmental and occupational safety codes. Identify unsafe conditions and stop or escalate work when appropriate. Support site emergency response activities involving facility or utility failures. QualificationsRequired QualificationsBachelors degree in Engineering Engineering Technology Facilities Engineering Mechanical Engineering Electrical Engineering or a related technical discipline; or an equivalent combination of education and relevant experience. Minimum of three (3) years of progressive experience in facilities engineering project engineering plant engineering maintenance engineering or a related discipline. Experience in a pharmaceutical biotechnology medical device food chemical or other regulated manufacturing environment. Working knowledge of cGMP requirements and their application to facilities utilities equipment and engineering activities. Demonstrated experience coordinating contractors vendors or external engineering service providers. Demonstrated project management experience including management of scope schedule cost contractors and project documentation. Working knowledge of HVAC electrical plumbing mechanical and building systems. Ability to interpret engineering drawings P&IDs equipment specifications and construction documents. Strong organizational communication problem-solving and project coordination skills. Ability to manage multiple projects and priorities with limited supervision. Preferred Qualifications5 years of experience in pharmaceutical or biotechnology manufacturing. Experience with GMP cleanrooms or aseptic manufacturing facilities. Experience with facility and utility commissioning and qualification. Familiarity with IQ/OQ/PQ ASTM E2500 GEP and risk-based qualification principles. Experience with CMMS systems and asset management. Experience with Building Management Systems (BMS/BAS). Experience developing capital project budgets and business cases. Experience with CAD or facility layout software. Experience with facility master planning or manufacturing space planning. Project Management Professional (PMP) Certified Facility Manager (CFM) or related certification. Key Skills & CapabilitiesStrong practical understanding of facility infrastructure within a regulated manufacturing environment. Ability to understand technical issues across multiple engineering disciplines and recognize when specialized engineering expertise is required. Strong contractor and vendor management skills including the ability to develop scopes of work and evaluate technical proposals. Strong project management skills across scope schedule cost risk and change management. Strong analytical troubleshooting and problem-solving skills. Ability to communicate effectively with skilled trades contractors engineers operators Quality Validation Maintenance and site leadership. Ability to work independently manage competing priorities and make sound decisions with limited supervision. Ability to influence outcomes and hold contractors and service providers accountable through technical expertise communication and coordination rather than direct authority. Ability to work effectively in a fast-paced changing manufacturing environment. Physical RequirementsAbility to work in manufacturing laboratory warehouse utility construction and office environments. Ability to enter controlled and GMP manufacturing areas and comply with applicable gowning and PPE requirements. Ability to routinely walk manufacturing and facility areas including stairs and mechanical spaces. Ability to occasionally lift carry push or pull materials or equipment components weighing up to 40 pounds. Ability to work around operating mechanical equipment electrical systems construction activities noise temperature variations and other industrial environments. Ability to work occasional off-hours weekends or shutdown periods when required to support critical projects or facility activities.#LI-Onsite #WH