Pharma Facilities Engineer: Projects & Utilities

Kindeva

Lexington (KY)

On-site

USD 85,000 - 115,000

Full time

5 days ago
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Job summary

Kindeva in Lexington, KY is seeking a Facilities Engineer to provide engineering support for our pharmaceutical manufacturing site. This individual contributor role leads facility and infrastructure projects, coordinates contractors, and supports site maintenance while ensuring operations meet cGMP standards.

You will partner with Engineering, Operations, Quality, Validation, and EHS to manage HVAC, electrical, plumbing, cleanrooms, and building automation, with a focus on safe, cost-effective

Qualifications

  • Bachelor's degree in Engineering or related technical discipline; or an equivalent combination of education and experience.
  • Minimum of three 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.

Responsibilities

  • Lead 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.
  • Serve 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.
  • Provide 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.
  • Ensure 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.
  • Maintain 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.
  • Ensure 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.

Skills

Contractor management
Project management
Cross-functional collaboration
Vendor coordination
Problem solving

Education

Bachelor's degree in Engineering or related technical discipline

Tools

CMMS systems
CAD / facility layout software
Building Management Systems (BMS/BAS)

Job description

Kindeva in Lexington, KY is seeking a Facilities Engineer to provide engineering support for our pharmaceutical manufacturing site. This individual contributor role leads facility and infrastructure projects, coordinates contractors, and supports site maintenance while ensuring operations meet cGMP standards.

You will partner with Engineering, Operations, Quality, Validation, and EHS to manage HVAC, electrical, plumbing, cleanrooms, and building automation, with a focus on safe, cost-effective

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