Description

Allegiance Industries is a facilities services and full-service electrical contractor serving the commercial, industrial, and retail markets in the southeast United States.

The Senior Critical Utilities & Controls Engineer is responsible for the technical oversight, reliability, and lifecycle management of site critical utilities and control systems within a GMP-regulated environment. This role serves as a lead role for building automation systems (BAS/BMS), PLC/HMI platforms, and central utilities including boilers, chillers, HVAC, and associated infrastructure.

The position drives system performance, compliance, and continuous improvement initiatives while ensuring alignment with GMP, GDP, and GLP standards. This role partners closely with Facilities, Quality, Validation, and Engineering teams and provides technical leadership and direction to site technicians and vendors.

Reporting to the Technical Manager, this individual plays a key role in ensuring audit readiness, system reliability, and long-term asset strategy.

Key Responsibilities

Technical Leadership & System Ownership

Serve as a lead for critical utilities systems including boilers, chillers, HVAC, compressed air, and water systems (e.g., WFI, clean steam where applicable)

Own and support BAS/BMS and PLC/HMI control systems, ensuring system integrity, performance, and cybersecurity awareness

Provide technical direction and mentorship to facilities technicians and third-party vendors

Lead troubleshooting of complex system issues and drive resolution to minimize operational impact

Support system design reviews, upgrades, and capital projects

Reliability Engineering & Maintenance Strategy

Develop and optimize preventative and predictive maintenance strategies for critical systems

Analyze system performance, trends, and failures to drive reliability improvements

Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA)

Ensure critical spares strategy and asset lifecycle planning are in place

Drive uptime, efficiency, and energy optimization initiatives

EAM / CMMS Governance

Oversee execution and quality of maintenance activities within the EAM/CMMS system (e.g., SAP)

Ensure accuracy of asset hierarchy, job plans, and maintenance records

Review and approve work orders, ensuring completeness and compliance with data integrity standards (ALCOA)

Support planning and scheduling activities in coordination with maintenance teams

GMP Compliance / Validation / Documentation

Ensure all systems and activities comply with GMP, GDP, and GLP standards

Support and lead change control, deviation investigations, and CAPA execution

Partner with Validation to maintain systems in a validated state, including support for IQ/OQ/PQ activities

Maintain audit-ready documentation and support internal/external regulatory inspections

Ensure adherence to all controlled procedures and documentation practices

Project & Continuous Improvement

Support capital projects involving utilities and control systems from design through commissioning

Identify and implement process improvements to enhance system reliability and compliance

Drive standardization of maintenance practices and documentation

Support digitalization and smart facilities initiatives (e.g., data analytics, remote monitoring)

Cross-Functional Collaboration

Interface with Quality, Manufacturing, Validation, and Engineering teams to ensure alignment on system performance and compliance

Act as the technical liaison for audits, inspections, and client interactions

Support training and development of site personnel on systems, procedures, and GMP expectations

Qualifications

5–10+ years of experience in a GMP-regulated environment (pharma, biotech, or life sciences)

Strong hands-on experience with critical utilities systems (boilers, chillers, HVAC, etc.)

Experience with BAS/BMS platforms and PLC/HMI troubleshooting

Proven experience with EAM/CMMS systems (Maximo, SAP, or similar)

Strong understanding of GMP documentation practices and data integrity (ALCOA principles)

Demonstrated experience leading troubleshooting and reliability initiatives

Preferred Qualifications

Bachelor’s degree in Engineering (Mechanical, Electrical, Controls, or related field)

Experience with validated systems and change control processes

Familiarity with regulatory inspections (FDA, EMA, etc.)

Experience in project engineering or capital project support

Knowledge of cybersecurity considerations for control systems

Core Competencies

Advanced troubleshooting and analytical thinking

Technical leadership and mentorship

Strong understanding of GMP compliance and audit readiness

High attention to detail and documentation excellence

Ability to influence cross-functional teams

Strategic thinking with hands-on execution capability

Work Environment

GMP-controlled / cleanroom and utility plant environments

Requires adherence to gowning, PPE, and safety protocols

Combination of field-based and office-based work

Key Performance Indicators (KPIs)

Critical utilities uptime and system reliability

PM/PdM program effectiveness and completion rates

Deviation reduction and RCA effectiveness

CMMS data integrity and work order quality

Audit findings related to facilities/utilities

Response and resolution time for critical system issues

Energy efficiency and system optimization metrics

Allegiance Industries

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Senior Critical Utilities & Controls Engineer (GMP Environment)