Nature and Scope of JobHiring 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.
Primary 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 ConditionsThe working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- 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 and evidence management.
- Frequently communicate with the Senior Controls Validation Engineer, facility operations staff, and controls technicians in person and via electronic communication channels.
DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
CompensationHourly Rate Range (W2): USD 60.00 - 80.00
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.
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.
For more details about our benefits, visit us here: https://usdm.com/careers
