Facilities Engineer
Kindeva Drug Delivery · Lexington, KY · 1 mo ago
On-siteManagementFull-time
We need to output HTML fragment with sections only if content present. Must not repeat job title. Must not include Job ID etc. Must remove boilerplate like "Our Work Matters At Kindeva..."? Actually that is part of description; we need to preserve substantive info. The initial paragraph about Kindeva mission etc is substantive? It's generic but maybe we keep as a for each section heading.
We need to decide which sections have content.
From posting:
- Intro: "Our Work Matters At Kindeva..." then "Why Kindeva?" bullet list: Purpose-driven work environment, Significant growth potential, Collaborative team culture, Direct impact on patient care, Industry-leading innovation. Then paragraph about Kindeva being more than a CDMO. Then "We're looking for a Facilities Engineer..." That's about the role. So we can put that under About the role.
- Responsibilities: clearly a big section with subheadings: Facilities & Capital Project Management, Contractor & Service Provider Management, Facilities & Utilities Engineering, GMP, Qualification & Change Control, Facility Planning, Asset Lifecycle & Maintenance Support, Safety & Compliance. Those are subheadings within responsibilities but we can keep as
. The instructions: "Preserve ALL substantive information; do NOT invent or summarize away detail." So we keep the description but not boilerplate like cookie/navigation/legal/EEO etc. The text includes "Our Work Matters At Kindeva, we make products..." That's part of job posting; we keep. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use
for each section heading.
We need to decide which sections have content.
From posting:
- Intro: "Our Work Matters At Kindeva..." then "Why Kindeva?" bullet list: Purpose-driven work environment, Significant growth potential, Collaborative team culture, Direct impact on patient care, Industry-leading innovation. Then paragraph about Kindeva being more than a CDMO. Then "We're looking for a Facilities Engineer..." That's about the role. So we can put that under About the role.
- Responsibilities: clearly a big section with subheadings: Facilities & Capital Project Management, Contractor & Service Provider Management, Facilities & Utilities Engineering, GMP, Qualification & Change Control, Facility Planning, Asset Lifecycle & Maintenance Support, Safety & Compliance. Those are subheadings within responsibilities but we can keep as - items? The instruction: Use
- for any list of duties/requirements/benefits. So we need to list duties as
- . The subheadings could be part of
- text or we could keep them as bold? Probably just include them within
- as part of description.
- Requirements: The posting has "Qualifications" with Required Qualifications and Preferred Qualifications. That is qualifications. So we can have a Requirements section? Actually they separate Requirements and Qualifications. The instruction says use headings for Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what content goes where.
We have Required Qualifications (education, experience, etc.) and Preferred Qualifications (additional). Also there is a "Key Skills & Capabilities" section. That could go under Skills.
Thus we can map:
- About the role: intro paragraphs.
- Responsibilities: list of duties (the big responsibilities section).
- Requirements: maybe the Required Qualifications? Or we could combine Required and Preferred under Qualifications. But we have both Requirements and Qualifications headings allowed. We could put Required Qualifications under Requirements, and Preferred Qualifications plus Key Skills under Qualifications? Or we could put all qualifications under Qualifications and leave Requirements empty (but we must not emit empty heading). So we need to decide.
Better: Use Requirements for the Required Qualifications (must-have). Use Qualifications for Preferred Qualifications and Key Skills & Capabilities (maybe also include physical requirements?). Physical Requirements could be under Requirements? Actually physical requirements are separate but could be part of Requirements. However we have a "Physical Requirements" subsection under Qualifications? It's after Key Skills & Capabilities. It could be part of Qualifications or Requirements. Since it's about ability to work etc., it's more like qualifications. We'll include under Qualifications.
Thus:
- Requirements: Required Qualifications bullet list.
- Qualifications: Preferred Qualifications, Key Skills & Capabilities, Physical Requirements.
- Skills: maybe we could separate but we already put skills under Qualifications. But we have a Skills heading allowed; we could put Key Skills & Capabilities there. However we already used Qualifications for preferred etc. Might be better to follow typical structure: Requirements = Required Qualifications; Qualifications = Preferred Qualifications; Skills = Key Skills & Capabilities; Benefits, Pay, Schedule: none present (no mention of benefits, pay, schedule). So we omit those sections.
Thus we will have sections: About the role, Responsibilities, Requirements, Qualifications, Skills.
Check if any content for Benefits, Pay, Schedule: none. So omit.
Now we need to format.
We need to preserve all substantive info. So we need to include the bullet points from "Why Kindeva?" as part of About the role maybe as
- . Also the paragraph about Kindeva being more than a CDMO.
We need to include the "Impact You Will Make" paragraph as part of About the role? Could be separate but we can include.
Thus About the role content:
- Paragraph: "Our Work Matters At Kindeva, we make products that improve people's lives. Every day, our teams develop and manufacture pharmaceutical therapies and medical devices that patients worldwide depend on."
- Then maybe a
- list for Why Kindeva? items.
- Then paragraph: "At Kindeva, we're more than a global Contract Development and Manufacturing Organization (CDMO). We're a team dedicated to improving patient outcomes through innovation, collaboration, and operational excellence."
- Then paragraph: "We're 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 growth."
- Then paragraph: "The Impact You Will Make As a Facilities Engineer, you will serve as a key technical resource connecting Engineering, Operations, Maintenance, Quality, Validation, EHS, contractors, and external engineering service providers. You 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 standards. You 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 growth. This is an individual contributor position with project and contractor leadership responsibilities and no direct reports."
We could keep that as part of About the role.
Now Responsibilities: we need to list duties. The responsibilities section has multiple sub-sections each with multiple bullet-like sentences. We'll convert each sentence or clause into
- . Might be many. We'll preserve all.
We'll need to parse the responsibilities text and create list items.
Let's extract responsibilities content:
Under "Responsibilities" heading:
- Facilities & Capital Project Management
- 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.
- Contractor & Service Provider Management
- 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.
- Facilities & Utilities Engineering
- 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.
- GMP, Qualification & Change Control
- 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.
- Facility Planning, Asset Lifecycle & Maintenance Support
- 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.
- Safety & Compliance
- 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.
Now Requirements: Required Qualifications bullet list:
- Bachelor's 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,
- for any list of duties/requirements/benefits. So we need to list duties as
- . The subheadings could be part of
- text or we could keep them as bold? Probably just include them within
- as part of description.
- Requirements: The posting has "Qualifications" with Required Qualifications and Preferred Qualifications. That is qualifications. So we can have a Requirements section? Actually they separate Requirements and Qualifications. The instruction says use headings for Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what content goes where.
We have Required Qualifications (education, experience, etc.) and Preferred Qualifications (additional). Also there is a "Key Skills & Capabilities" section. That could go under Skills.
Thus we can map:
- About the role: intro paragraphs.
- Responsibilities: list of duties (the big responsibilities section).
- Requirements: maybe the Required Qualifications? Or we could combine Required and Preferred under Qualifications. But we have both Requirements and Qualifications headings allowed. We could put Required Qualifications under Requirements, and Preferred Qualifications plus Key Skills under Qualifications? Or we could put all qualifications under Qualifications and leave Requirements empty (but we must not emit empty heading). So we need to decide.
Better: Use Requirements for the Required Qualifications (must-have). Use Qualifications for Preferred Qualifications and Key Skills & Capabilities (maybe also include physical requirements?). Physical Requirements could be under Requirements? Actually physical requirements are separate but could be part of Requirements. However we have a "Physical Requirements" subsection under Qualifications? It's after Key Skills & Capabilities. It could be part of Qualifications or Requirements. Since it's about ability to work etc., it's more like qualifications. We'll include under Qualifications.
Thus:
- Requirements: Required Qualifications bullet list.
- Qualifications: Preferred Qualifications, Key Skills & Capabilities, Physical Requirements.
- Skills: maybe we could separate but we already put skills under Qualifications. But we have a Skills heading allowed; we could put Key Skills & Capabilities there. However we already used Qualifications for preferred etc. Might be better to follow typical structure: Requirements = Required Qualifications; Qualifications = Preferred Qualifications; Skills = Key Skills & Capabilities; Benefits, Pay, Schedule: none present (no mention of benefits, pay, schedule). So we omit those sections.
Thus we will have sections: About the role, Responsibilities, Requirements, Qualifications, Skills.
Check if any content for Benefits, Pay, Schedule: none. So omit.
Now we need to format.
We need to preserve all substantive info. So we need to include the bullet points from "Why Kindeva?" as part of About the role maybe as
- . Also the paragraph about Kindeva being more than a CDMO.
We need to include the "Impact You Will Make" paragraph as part of About the role? Could be separate but we can include.
Thus About the role content:
- Paragraph: "Our Work Matters At Kindeva, we make products that improve people's lives. Every day, our teams develop and manufacture pharmaceutical therapies and medical devices that patients worldwide depend on."
- Then maybe a
- list for Why Kindeva? items. - Then paragraph: "At Kindeva, we're more than a global Contract Development and Manufacturing Organization (CDMO). We're a team dedicated to improving patient outcomes through innovation, collaboration, and operational excellence." - Then paragraph: "We're 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 growth." - Then paragraph: "The Impact You Will Make As a Facilities Engineer, you will serve as a key technical resource connecting Engineering, Operations, Maintenance, Quality, Validation, EHS, contractors, and external engineering service providers. You 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 standards. You 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 growth. This is an individual contributor position with project and contractor leadership responsibilities and no direct reports." We could keep that as part of About the role. Now Responsibilities: we need to list duties. The responsibilities section has multiple sub-sections each with multiple bullet-like sentences. We'll convert each sentence or clause into
- . Might be many. We'll preserve all. We'll need to parse the responsibilities text and create list items. Let's extract responsibilities content: Under "Responsibilities" heading: - Facilities & Capital Project Management - 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. - Contractor & Service Provider Management - 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. - Facilities & Utilities Engineering - 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. - GMP, Qualification & Change Control - 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. - Facility Planning, Asset Lifecycle & Maintenance Support - 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. - Safety & Compliance - 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. Now Requirements: Required Qualifications bullet list: - Bachelor's 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,
- . Also the paragraph about Kindeva being more than a CDMO.
We need to include the "Impact You Will Make" paragraph as part of About the role? Could be separate but we can include.
Thus About the role content:
- Paragraph: "Our Work Matters At Kindeva, we make products that improve people's lives. Every day, our teams develop and manufacture pharmaceutical therapies and medical devices that patients worldwide depend on."
- Then maybe a