NCBiotech
Job Description
The Executive Director, Maintenance and Engineering leads the HPV, VMF, Flash and Teknika Production Areas Maintenance, Clean Utilities, Site-wide Utilities, Site Services, and Site Engineering functions for the Durham site. As a member of the Durham Site Leadership Team, this role provides strategic and tactical direction to ensure asset reliability, cGMP/EHS compliance, effective shutdown and project execution, and efficient operations within budget. The leader drives continuous improvement, fosters an inclusive and positive culture, and partners with Operations/IPTs, GES, COEs, Automation, Reliability, Quality, EHS, and Finance to achieve safety, quality, service, and cost objectives. Key Responsibilities
Strategy and Leadership
Set the vision and multi‑year strategy for maintenance, utilities, and engineering aligned to business goals, capacity needs, and compliance requirements. Serve on the Durham Site Leadership Team; influence site priorities and resource allocation. Build and develop a high‑performing organization (200 employees) including associate directors, managers, engineers, technicians, and coordinators; coach/mentor leaders and ICs. Promote an inclusive, positive culture emphasizing safety, quality, continuous improvement, and accountability. Compliance, Quality, and EHS
Ensure all Maintenance, Utilities, Site Services, and Engineering processes comply with cGMP; Safety; Environmental; Industrial Hygiene; ANSI and Labor regulations. Own audit readiness and respond to/resolve compliance gaps from audits and deviations; lead or support investigations and corrective/preventive actions (CAPA). Establish and enforce procedures for lockout/tagout, machine guarding, risk assessments, Electrical Safety, Hot Work, Line Breaking, Confined Space, Elevated Work, PSM elements as applicable, and contractor management. Maintenance and Calibration Operations
Direct preventive, predictive, and corrective maintenance programs HPV, Flash, VMF and Teknika production equipment, clean utilities, facilities, and site services. Ensure equipment calibration programs are GMP‑compliant; maintain integrity of equipment identification and specifications within the computerized maintenance/calibration management system. Manage shop floor support to meet safety, compliance, production, and financial goals; reduce reactive work by analyzing completed work orders and driving reliability actions. Oversee spare parts strategy including risk‑based assessments, obsolescence replacement, storeroom controls, and SAP plant maintenance/spare parts procurement processes. Utilities and Site Services
Lead operation and maintenance of all plant utilities and distribution networks: boilers, refrigeration, HVAC, electrical substations, compressed air, potable/distilled water, dust collection, wastewater, storm water, and related systems. Coordinate site services (building, building services, grounds, waste, and facility support) to ensure reliable, compliant operation. Drive sustainability initiatives, ensuring regulatory compliance and implementing strategies for continuous improvement. Reliability and Continuous Improvement
Partner with reliability engineers to conduct RBAM, RCM/FMEA, root cause analysis, and implement area‑specific reliability actions to improve uptime, MTBF/MTTR, and OEE. Collaborate with Automation for troubleshooting and maintenance of automated equipment; engage vendors and OEMs to resolve complex issues and improve performance. Monitor performance of maintenance, calibration, equipment, and utilities operations; identify improvement opportunities and drive continuous improvement initiatives. Shutdown and Turnaround Management
Own master shutdown schedules and execution across maintenance, calibration, capital project work, and GMP cleaning; chair/attend daily shutdown meetings to track completion. Background in reliability engineering, RBAM/RCM/FMEA, and root cause analysis. Experience with shutdown/turnaround management and multi‑site coordination. Familiarity with automation/controls and vendor/OEM management. Certifications: PMP, CMRP/CRE, Six Sigma/Lean, PE or equivalent. Key Performance Indicators (KPIs)
Asset availability/OEE; equipment reliability (MTBF/MTTR) Planned vs. reactive work ratio; maintenance backlog Calibration compliance and audit outcomes Utilities uptime and energy efficiency Safety performance (RIR, near‑miss closure, LOTO compliance) Budget adherence (OPEX/CAPEX), spare parts inventory accuracy/turns Capital project delivery (scope, schedule, cost, qualification/closeout) Education
Bachelor’s degree in Engineering, Science, or a closely related technical field (Mechanical, Electrical, Chemical, Industrial, or similar) Advanced degree (MS/MBA) or Professional Engineer (PE) preferred Required Experience and Skills
15+ years total in industrial plant engineering, maintenance, and/or utilities management within GMP or highly regulated manufacturing environments, covering production equipment, clean utilities, building services, and facilities/utilities project engineering. 5+ years leading people, including through managers and individual contributors, in multi-disciplinary maintenance/engineering organizations. Technical Skills
Track record owning maintenance and calibration programs, reliability improvement initiatives, and capital project delivery (scope, cost, schedule, quality, qualification/validation). Proficiency with CMMS/EAM and GMP‑compliant calibration systems; experience analyzing maintenance data to reduce reactive work and increase reliability. Working knowledge of SAP (Plant Maintenance and spare parts procurement) or equivalent ERP. Strong understanding of utilities operations (boilers, refrigeration, HVAC, electrical distribution, compressed air, water systems, wastewater/storm water) and associated regulatory requirements. Familiarity with automation/controls environments and collaboration with OEMs/vendors. Compliance and Safety
Demonstrated knowledge of cGMP, EHS, and relevant Safety, Environmental, Industrial Hygiene, and Labor regulations. Experience leading audits/inspections, deviations, investigations, and CAPA. Leadership and Business
Strong planning, scheduling, budgeting, and financial acumen for OPEX/CAPEX management. Excellent analytical, decision‑making, and problem‑solving skills; effective written and oral communication. Proven ability to drive continuous improvement and foster an inclusive, positive team culture. Preferred Experience and Skills
Certifications: PMP, CMRP/CRE, Six Sigma/Lean. Experience with shutdown/turnaround management and multi‑site/COE collaboration. Direct experience in pharmaceutical or biopharmaceutical manufacturing, including equipment qualification/validation and change control. Competencies
Strategic thinking and execution Technical depth in maintenance, utilities, and engineering Financial acumen and cost control Compliance and risk management Continuous improvement and problem solving Coaching, talent development, and inclusive leadership Stakeholder influence and cross‑functional collaboration Required Skills
Accountability, Contractor Oversight, Cross‑Cultural Awareness, Customer‑Focused, Customer Service Leadership, Engineering Design, Ethical Compliance, Facility Management, Innovation, Leadership, Management Process, Operations Management, People Leadership, Professional Engineering, Risk Management, Team Leadership, Utilities Management, Visionary Thinking Preferred Skills
Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only
We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. Equal Employment Opportunity Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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The Executive Director, Maintenance and Engineering leads the HPV, VMF, Flash and Teknika Production Areas Maintenance, Clean Utilities, Site-wide Utilities, Site Services, and Site Engineering functions for the Durham site. As a member of the Durham Site Leadership Team, this role provides strategic and tactical direction to ensure asset reliability, cGMP/EHS compliance, effective shutdown and project execution, and efficient operations within budget. The leader drives continuous improvement, fosters an inclusive and positive culture, and partners with Operations/IPTs, GES, COEs, Automation, Reliability, Quality, EHS, and Finance to achieve safety, quality, service, and cost objectives. Key Responsibilities
Strategy and Leadership
Set the vision and multi‑year strategy for maintenance, utilities, and engineering aligned to business goals, capacity needs, and compliance requirements. Serve on the Durham Site Leadership Team; influence site priorities and resource allocation. Build and develop a high‑performing organization (200 employees) including associate directors, managers, engineers, technicians, and coordinators; coach/mentor leaders and ICs. Promote an inclusive, positive culture emphasizing safety, quality, continuous improvement, and accountability. Compliance, Quality, and EHS
Ensure all Maintenance, Utilities, Site Services, and Engineering processes comply with cGMP; Safety; Environmental; Industrial Hygiene; ANSI and Labor regulations. Own audit readiness and respond to/resolve compliance gaps from audits and deviations; lead or support investigations and corrective/preventive actions (CAPA). Establish and enforce procedures for lockout/tagout, machine guarding, risk assessments, Electrical Safety, Hot Work, Line Breaking, Confined Space, Elevated Work, PSM elements as applicable, and contractor management. Maintenance and Calibration Operations
Direct preventive, predictive, and corrective maintenance programs HPV, Flash, VMF and Teknika production equipment, clean utilities, facilities, and site services. Ensure equipment calibration programs are GMP‑compliant; maintain integrity of equipment identification and specifications within the computerized maintenance/calibration management system. Manage shop floor support to meet safety, compliance, production, and financial goals; reduce reactive work by analyzing completed work orders and driving reliability actions. Oversee spare parts strategy including risk‑based assessments, obsolescence replacement, storeroom controls, and SAP plant maintenance/spare parts procurement processes. Utilities and Site Services
Lead operation and maintenance of all plant utilities and distribution networks: boilers, refrigeration, HVAC, electrical substations, compressed air, potable/distilled water, dust collection, wastewater, storm water, and related systems. Coordinate site services (building, building services, grounds, waste, and facility support) to ensure reliable, compliant operation. Drive sustainability initiatives, ensuring regulatory compliance and implementing strategies for continuous improvement. Reliability and Continuous Improvement
Partner with reliability engineers to conduct RBAM, RCM/FMEA, root cause analysis, and implement area‑specific reliability actions to improve uptime, MTBF/MTTR, and OEE. Collaborate with Automation for troubleshooting and maintenance of automated equipment; engage vendors and OEMs to resolve complex issues and improve performance. Monitor performance of maintenance, calibration, equipment, and utilities operations; identify improvement opportunities and drive continuous improvement initiatives. Shutdown and Turnaround Management
Own master shutdown schedules and execution across maintenance, calibration, capital project work, and GMP cleaning; chair/attend daily shutdown meetings to track completion. Background in reliability engineering, RBAM/RCM/FMEA, and root cause analysis. Experience with shutdown/turnaround management and multi‑site coordination. Familiarity with automation/controls and vendor/OEM management. Certifications: PMP, CMRP/CRE, Six Sigma/Lean, PE or equivalent. Key Performance Indicators (KPIs)
Asset availability/OEE; equipment reliability (MTBF/MTTR) Planned vs. reactive work ratio; maintenance backlog Calibration compliance and audit outcomes Utilities uptime and energy efficiency Safety performance (RIR, near‑miss closure, LOTO compliance) Budget adherence (OPEX/CAPEX), spare parts inventory accuracy/turns Capital project delivery (scope, schedule, cost, qualification/closeout) Education
Bachelor’s degree in Engineering, Science, or a closely related technical field (Mechanical, Electrical, Chemical, Industrial, or similar) Advanced degree (MS/MBA) or Professional Engineer (PE) preferred Required Experience and Skills
15+ years total in industrial plant engineering, maintenance, and/or utilities management within GMP or highly regulated manufacturing environments, covering production equipment, clean utilities, building services, and facilities/utilities project engineering. 5+ years leading people, including through managers and individual contributors, in multi-disciplinary maintenance/engineering organizations. Technical Skills
Track record owning maintenance and calibration programs, reliability improvement initiatives, and capital project delivery (scope, cost, schedule, quality, qualification/validation). Proficiency with CMMS/EAM and GMP‑compliant calibration systems; experience analyzing maintenance data to reduce reactive work and increase reliability. Working knowledge of SAP (Plant Maintenance and spare parts procurement) or equivalent ERP. Strong understanding of utilities operations (boilers, refrigeration, HVAC, electrical distribution, compressed air, water systems, wastewater/storm water) and associated regulatory requirements. Familiarity with automation/controls environments and collaboration with OEMs/vendors. Compliance and Safety
Demonstrated knowledge of cGMP, EHS, and relevant Safety, Environmental, Industrial Hygiene, and Labor regulations. Experience leading audits/inspections, deviations, investigations, and CAPA. Leadership and Business
Strong planning, scheduling, budgeting, and financial acumen for OPEX/CAPEX management. Excellent analytical, decision‑making, and problem‑solving skills; effective written and oral communication. Proven ability to drive continuous improvement and foster an inclusive, positive team culture. Preferred Experience and Skills
Certifications: PMP, CMRP/CRE, Six Sigma/Lean. Experience with shutdown/turnaround management and multi‑site/COE collaboration. Direct experience in pharmaceutical or biopharmaceutical manufacturing, including equipment qualification/validation and change control. Competencies
Strategic thinking and execution Technical depth in maintenance, utilities, and engineering Financial acumen and cost control Compliance and risk management Continuous improvement and problem solving Coaching, talent development, and inclusive leadership Stakeholder influence and cross‑functional collaboration Required Skills
Accountability, Contractor Oversight, Cross‑Cultural Awareness, Customer‑Focused, Customer Service Leadership, Engineering Design, Ethical Compliance, Facility Management, Innovation, Leadership, Management Process, Operations Management, People Leadership, Professional Engineering, Risk Management, Team Leadership, Utilities Management, Visionary Thinking Preferred Skills
Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only
We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. Equal Employment Opportunity Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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