Senior Associate Director of Maintenance Leadership

KEVIN E. DODDS

Oceanside, CA

Phone: 760-***-****, E-Mail: *******@***.***

Director of Reliability, Metrology & Asset Management Engineering and operations leader with 30+ years of experience driving calibration, metrology, reliability engineering, and asset lifecycle programs across pharmaceutical, biotech, aerospace, and energy environments. Proven record of building compliant systems aligned with ISO/IEC 17025, GMP, and regulatory standards, leading cross-functional teams, and delivering large-scale asset management transformations. Expert in preventive maintenance optimization, criticality analysis, SOP governance, and reliability-driven cost reduction.

• Led enterprise-wide asset and calibration programs supporting pharmaceutical and biotech manufacturing sites.

• Directed ISO/IEC 17025 accreditation initiatives, audits, and laboratory compliance programs.

• Delivered $100K+ in first-year cost savings through asset rationalization and workflow optimization.

• Managed and mentored teams of up to 15+ engineers and technicians across multi-site operations.

• Successfully transitioned global facilities to new CCMS platforms, including validation and training.

• Designed maintenance and reliability programs for greenfield energy and LNG facilities. AREAS OF EXPERTISE

Calibration & Metrology Engineering

Reliability & Asset Lifecycle Management

ISO/IEC 17025 & GMP Compliance

Preventive & Predictive Maintenance Programs

Asset Criticality Ranking & Risk Management

Computerized Maintenance & Calibration Systems (CMMS/CCMS)

SOP Development, Governance & Validation

Root Cause Analysis, CAPA & Fault Analysis

KPI Development & Performance Optimization

Lean Six Sigma & Continuous Improvement

Cross-Functional Team Leadership

Regulatory Audits & Gap Assessments

PROFESSIONAL EXPERIENCE

G.L. TECHNOLOGIES JAN 2020 – PRESENT

DIRECTOR OF METROLOGY ENGINEERING (JAN 2020 – PRESENT) MAJOR CONTRIBUTIONS

Conduct gap analysis audits aligned with ISO/IEC 17025 requirements for calibration laboratories.

Develop and revise SOPs to improve laboratory efficiency, compliance, and inspection readiness.

Train metrology leadership and technical staff on regulatory standards and best practices.

Support laboratory accreditation initiatives and continuous improvement programs. MENTOR TECHNICAL GROUP SEP 2023 – JUN 2025

DIRECTOR OF ASSET MANAGEMENT (SEP 2023 – JUN 2025) MAJOR CONTRIBUTIONS

Directed asset lifecycle management for Thermo Fisher Scientific sites in Carlsbad, CA and Eugene, OR.

Established a Master Asset List, integrating calibration, maintenance, and repair workflows.

Delivered $100K in cost savings in the first year through process optimization and asset rationalization.

Applied root cause analysis to recurring failures, improving asset availability and uptime.

Reduced maintenance backlog and improved scheduling effectiveness across sites. TRIAD UNLIMITED, INC. JAN 2020 – JUN 2023

PRINCIPAL RELIABILITY & CALIBRATION ENGINEER (JAN 2020 – JUN 2023) MAJOR CONTRIBUTIONS

Led a 7-member team transitioning the Pfizer McPherson, KS facility to a new CCMS.

Performed equipment walkdowns, asset criticality assessments, and system validation activities.

Authored and managed site-wide SOPs for calibration, maintenance, and work execution.

Delivered end-user training for CCMS work order execution, review, and closure.

Partnered with SMEs to design maintenance strategies for a new LNG production facility. GENESIS SOLUTIONS JAN 2016 – JAN 2020

PRINCIPAL RELIABILITY ENGINEER / PROJECT MANAGER (JAN 2016 – JAN 2020) MAJOR CONTRIBUTIONS

Managed a 12-member engineering team supporting Gilead Sciences’ La Verne facility.

Developed preventive maintenance and calibration programs for new and existing assets.

Delivered system asset lists, job plans, PMs, work orders, and criticality rankings.

Coordinated with SMEs, commissioning teams, and quality groups to meet regulatory timelines. GENENTECH, INC. – OCEANSIDE, CA JAN 2003 – JAN 2016 PRINCIPAL RELIABILITY ENGINEER / SUPERVISOR (2010 – 2016) MAJOR CONTRIBUTIONS

Oversaw instrumentation reliability programs and calibration interval management.

Supported and maintained ISO/IEC 17025 accreditation for primary standards laboratories.

Led fault investigations, CAPA approvals, and Lean Six Sigma cost-reduction initiatives. SENIOR SUPERVISOR – NETWORK PRIMARY STANDARDS LABORATORY (2008 – 2016) MAJOR CONTRIBUTIONS

Directed network primary standards laboratory operations supporting enterprise calibration traceability and measurement accuracy.

Maintained ISO/IEC 17025 compliance through standards governance, interval control, and audit readiness.

Oversaw laboratory KPIs, technician performance, and corrective actions impacting multi-site calibration programs. PRINCIPAL RELIABILITY ENGINEER (2004 – 2008)

MAJOR CONTRIBUTIONS

Designed reliability engineering strategies for manufacturing instrumentation across regulated biotech environments.

Established preventive maintenance, calibration intervals, and failure analysis processes aligned with GMP requirements.

Performed root cause analysis and implemented corrective actions to improve asset availability and lifecycle performance.

SUPERVISOR – INSTRUMENTATION SERVICES (2003 – 2004) MAJOR CONTRIBUTIONS

Led instrumentation services teams supporting plant-wide calibration, maintenance, and troubleshooting activities.

Ensured GMP-compliant execution of work orders, documentation, and inspection readiness.

Coordinated with operations and engineering to minimize downtime and maintain production schedules. EARLIER CAREER HIGHLIGHTS

Genentech, Inc. Lead Technician, Clinical Plant Operations Jan 2002 – Jan 2003

Gilead Sciences Supervisor, Calibration Department Jan 1993 – Jan 2002

McDonnell Douglas Lead Technician, Calibration Department Jan 1988 – Jan 1993

United States Marine Corps Metrology Technician Jan 1981 – Jan 1988 EDUCATION

Master of Business Administration (MBA), Management American Intercontinental University

Bachelor of Science, Electronic Engineering Technology United States International University CERTIFICATIONS

Certified Maintenance & Reliability Professional (CMRP)

Lean Six Sigma Green Belt

Process Improvement Facilitator

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