Sr. Validation Engineer

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients.

Nature and Scope of Job

Hiring a Senior Controls Validation Engineer to lead the technical validation effort for a Building Management System (BMS) and Environmental Monitoring System (EMS) at a GxP-regulated cell therapy manufacturing facility located on-site in Winston-Salem, NC. The successful candidate will own protocol authorship, sequence-of-operation interpretation, risk assessment, and execution oversight, and will serve as the primary technical point of contact with controls documentation and quality/engineering stakeholders. This is a hands-on, documentation-intensive role requiring both deep BAS/controls expertise and a strong command of GxP validation methodology.

Primary Responsibilities

• Author and approve the Validation Plan, risk assessment, and IQ/OQ protocols based on EcoStruxure as-built drawings and sequences of operation.
• Interpret complex control sequences — including AHU lead/standby switching, boiler lead/lag cascade, room pressurization cascade, and EMS alarm logic — and translate them into testable, traceable acceptance criteria.
• Lead OQ execution and troubleshooting for BACnet IP/MS-TP, LON, and RS-485 network segments, and for controller-level logic across Schneider Electric MP-C, MP-V, and AS-P/UI-16/DO-FA-12-H platforms.
• Review and approve field verification of EMS instrumentation (temperature, relative humidity, CO2, O2, and differential pressure) against calibration records.
• Manage deviations, drive root-cause investigation for any test failures, and approve corrective test reruns.
• Author the Validation Summary Report and present validation status and results to quality and engineering leadership.
• Mentor and review the work of the Junior Controls Validation Engineer, including test script execution and evidence collection.
• Maintain Requirements Traceability Matrices (RTM) linking system requirements to design specifications, test scripts, and executed test evidence.
• Ensure all validation documentation meets GxP standards and is prepared for regulatory inspection readiness.

Required Qualifications

• Minimum 7 years of building automation/controls engineering experience, including direct hands-on work with Schneider Electric EcoStruxure Building Operation or a comparable BAS platform (e.g., Johnson Controls Metasys, Siemens Desigo, or Honeywell).
• Minimum 3 years performing or leading computer system validation (CSV) in a GxP-regulated environment (pharmaceutical, biotech, or medical device manufacturing).
• Demonstrated experience validating cleanroom environmental monitoring systems (temperature, relative humidity, differential pressure, and gas monitoring) supporting ISO 7/ISO 8 classified spaces or equivalent.
• Working knowledge of BACnet IP/MS-TP, LON, and Modbus/RS-485 network protocols in a life sciences facility context.
• Familiarity with 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 risk-based validation methodology.
• Ability to interpret as-built drawings, sequences of operation, panel schedules, and point-to-point wiring diagrams.
• Strong written communication skills with the ability to produce clear, traceable, and audit-ready validation documentation.
• Ability to work on-site in Winston-Salem, NC for the duration of the engagement.

Preferred Qualifications

• Prior experience validating cell therapy or gene therapy manufacturing support systems, including biosafety cabinets, CO2/O2 incubators, and ultra-low temperature freezers.
• Experience authoring or reviewing sequences of operation for AHU lead/standby, boiler lead/lag, and pressure cascade control strategies.
• Certified Controls Systems Technician (CSST) credential or equivalent Schneider Electric EcoStruxure certification.
• Experience leading validation teams or mentoring junior engineers in a regulated environment.
• Familiarity with ISPE GAMP 5 or formal CSV training from a recognized life sciences institution.

Education & Certifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Controls Engineering, or a related technical discipline required.
• Equivalent hands-on BAS/EMS experience in lieu of formal degree will be considered.

Working Conditions

This is a full-time, on-site position located in Winston-Salem, NC. Regular on-site presence is required throughout the duration of the engagement. Work is performed in a GxP-regulated cell therapy manufacturing facility, including cleanroom support areas, mechanical rooms, and equipment rooms. Appropriate facility access and safety protocols must be followed. Prolonged periods of standing, walking, and working in mechanical/electrical equipment areas during field verification activities. Operate computers and office productivity equipment for documentation authoring, review, and evidence management. Frequently communicate with engineering, quality, and vendor stakeholders in person, via telephone, and via electronic communication channels.

Compensation

Hourly Rate Range (W2): USD 80.00–100.00

The hourly rate range represents the anticipated low and high end of USDM's compensation range for this position. Actual hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.