Executive Director, Engineering

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 multiyear 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:

• Bachelors 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:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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