Jr. Validation Engineer

About the role

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

Hiring a Junior Controls Validation Engineer to support hands-on test execution, field verification, and validation documentation 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. This is a developing-engineer role suited to someone building a career in GxP controls validation, working under the direct oversight of a Senior Controls Validation Engineer. Strong attention to detail, accurate and contemporaneous record-keeping, and a willingness to learn GxP documentation standards are essential.

Responsibilities

• Execute approved IQ/OQ test scripts under the direction of the Senior Controls Validation Engineer, including field verification of controllers, panels, and instrumentation against as-built drawings.
• Record and organize test evidence — including screenshots, trend data, alarm logs, and calibration certificates — with the completeness and traceability required for a GxP-regulated test record.
• Verify point-to-point wiring, device addressing, and controller configuration for VAV box controllers, EMS input/output modules, and network switches against panel and wiring schedules.
• Support field walkdowns confirming installed alarm stack lights, room pressure differentials, and instrument locations match the as-built room and differential pressure transmitter (DPT) schedules.
• Assist with deviation documentation, redline markup of test scripts, and organization of the traceability matrix.
• Escalate discrepancies between as-built documentation and field conditions to the Senior Controls Validation Engineer promptly and accurately.
• Maintain organized, inspection-ready validation binders and electronic records in accordance with site procedures.
• Assist with scheduling and logistics for field execution activities, including coordination with facility operations and controls technicians.

Required Qualifications

• 0–3 years of experience in building automation, controls, or instrumentation — internship, apprenticeship, or technician-level BAS experience is acceptable.
• Ability to read and interpret control drawings, panel schedules, and point-to-point wiring diagrams.
• Basic understanding of HVAC systems (air handling units, VAV boxes, exhaust systems) and building automation concepts including setpoints, sequences, and alarm management.
• Comfortable working in a regulated documentation environment — attention to detail and accurate, contemporaneous record-keeping are essential.
• Strong organizational skills and the ability to manage and file test evidence accurately across multiple concurrent test scripts.
• Ability to work on-site in Winston-Salem, NC for the duration of the engagement.

Preferred Qualifications

• Prior exposure to a GxP, pharmaceutical, biotech, or medical device manufacturing environment, even in an administrative, technician, or internship capacity.
• Familiarity with BACnet-based building automation systems, specifically Schneider Electric EcoStruxure or StruxureWare.
• Coursework or training in quality systems, computer system validation (CSV), or GAMP 5.
• Experience using electronic document management systems (EDMS) or regulated quality systems.

Education & Certifications

• Associate's or Bachelor's degree in Electrical Engineering Technology, Mechanical Engineering Technology, Controls/Instrumentation Engineering, or a related field required.
• Equivalent military, trade, or BAS technician training in lieu of formal degree will be considered.

Working Conditions

• 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 and evidence management.
• Frequently communicate with the Senior Controls Validation Engineer, facility operations staff, and controls technicians in person and via electronic communication channels.

Pay

Hourly Rate Range (W2): USD 60.00 – 80.00

Benefits

• Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
• Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan.
• Full and part-time employees may be eligible for paid time off.
• All employees are eligible for USDM's rewards and recognition program.