Senior Validation Engineer - GxP Life Sciences (On-Site)

USDM Life Sciences; Winston-Salem (NC); On-site; USD 229,233,000 - 286,541,000; Full time

Job summary

USDM Life Sciences in Winston-Salem, NC is seeking a Senior Controls Validation Engineer to lead the validation of a Building Management System and Environmental Monitoring System at a GxP‑regulated cell therapy facility.

You will own validation plans, test protocols, risk assessments, OQ, and the validation summary, while mentoring junior engineers and ensuring audit-ready documentation. On-site, full-time role with collaboration across quality and engineering leadership.

Qualifications

• 7+ years building automation/controls engineering experience.
• 3+ years performing or leading CSV in a GxP-regulated environment.
• Experience validating cleanroom EMS systems per ISO 7/ISO 8.

Responsibilities

• Author and approve Validation Plan, risk assessment, and IQ/OQ protocols.
• Interpret complex control sequences and translate to test criteria.
• Lead OQ and troubleshoot network segments (BACnet/IP/LON/RS-485).
• Review field verification of EMS instrumentation against records.
• Manage deviations and approve corrective test reruns.
• Author Validation Summary Report for leadership review.
• Mentor junior controls validation engineers and manage RTM.
• Ensure documentation meets GxP standards for audits.

Skills

Controls engineering

CSV experience

GxP validation

BAS/EMS

Education

Bachelor's degree in Mechanical/Electrical/Controls Engineering

Tools

EcoStruxure BAS

Metasys

Desigo

Job description

USDM Life Sciences in Winston-Salem, NC is seeking a Senior Controls Validation Engineer to lead the validation of a Building Management System and Environmental Monitoring System at a GxP‑regulated cell therapy facility.

You will own validation plans, test protocols, risk assessments, OQ, and the validation summary, while mentoring junior engineers and ensuring audit-ready documentation. On-site, full-time role with collaboration across quality and engineering leadership.