Senior GMP Automation & LIMS Lead

CAMRIS International; Silver Spring (MD); On-site; USD 105,000 - 155,000; Full time

Job summary

CAMRIS International seeks a Lead Systems Specialist to support the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research in Silver Spring, MD. You will lead automation, data integrity, and system lifecycle activities across LIMS, PLCs, and middleware.

Strong PLC/DCS/SCADA experience, SQL/data analysis, and a solid grasp of GMP/GxP quality systems are required to ensure compliance with 21 CFR Part 11 and ALCOA+ data integrity principles.

Qualifications

• Bachelor's degree in a technical field.
• Understanding of GMP, data integrity, GAMP, ICH Q9.
• 5+ years in R&D/MSAT/GMP environments with enterprise software or lab informatics.

Responsibilities

• Lead data integrity tasks and automate testing workflows.
• Bridge bench scientists, QA, and IT infrastructure teams.
• Configure and maintain automation systems including PLCs and interfaces.
• Lead design, implementation, commissioning, and lifecycle management of automation systems.
• Ensure GxP and 21 CFR Part 11 compliance and data integrity.

Skills

LIMS administration

Automation & controls

SQL & data analysis

Regulatory/GxP knowledge

Clear communication

Education

Bachelor's degree in Engineering/CS/IS/related

Tools

LabVantage

OSIsoft PI

Crystal Reports

PLC/SCADA/DCS/HMI

Job description

CAMRIS International seeks a Lead Systems Specialist to support the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research in Silver Spring, MD. You will lead automation, data integrity, and system lifecycle activities across LIMS, PLCs, and middleware.

Strong PLC/DCS/SCADA experience, SQL/data analysis, and a solid grasp of GMP/GxP quality systems are required to ensure compliance with 21 CFR Part 11 and ALCOA+ data integrity principles.