Senior Critical Utilities & Controls Engineer (GMP Environment)

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 Engineeris responsible forthe technical oversight reliability and lifecycle management of site critical utilities and control systems within a GMP-regulated environment. This role serves asa lead rolefor 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 asa leadfor 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 andoptimizepreventative 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 activitiescomply withGMP GDP and GLP standards

• Support and lead change control deviation investigations and CAPA execution

• Partner with Validation tomaintainsystems 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

• Identifyand 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

• 510 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

• Bachelors 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/PdMprogram 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