Lead Automation & LIMS Specialist (GxP)

CAMRIS International, LLC; Silver Spring (MD); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Job summary

CAMRIS International, LLC seeks a Lead Systems Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research in Silver Spring, MD. You will lead data integrity tasks, configure automated workflows, and serve as the bridge between bench scientists, QA, and IT infrastructure teams.

Collaborate with process engineers, scientists, operators, maintenance personnel, and vendors to identify automation opportunities and drive efficiencies.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Systems, Chemistry, Biology, or a related field.
• Understanding of GMP manufacturing practices and regulated computerized systems including data integrity and Good Automated Manufacturing Practice (GAMP) and ICH Q9.

Responsibilities

• Lead data integrity tasks including setup of testing workflows, configuring user access controls, integrating peripherals, setting automated schedules, managing alarms and general software administration tasks.
• Support cross-Functional teams acting as the main bridge between bench scientists, quality assurance (QA), and IT infrastructure teams.
• Collaborate with process engineers, scientists, operators, maintenance personnel, and vendors to identify opportunities for automation improvements and operational efficiencies.
• Communicate effectively, efficiently, and persistently with internal and external stakeholders including WRAIR Information Management Division, the PBF director and CAMRIS staff)
• Configure, maintain, troubleshoot, and optimize automation and control systems, including PLCs, machine to machine interfaces, and process data backups.
• Lead automation system design, implementation, commissioning, qualification, operation, and lifecycle management activities.
• Compliance & Validation: Ensuring data integrity, maintaining audit trails, and supporting GxP or regulatory standards (such as ISO/EPA guidelines).
• Assist WRAIR Information Management Division (IMD) and PBF end users with troubleshooting and upgrading applications supporting resolution of technical snags, data migrations, writing custom scripts or reports (e.g., LabVantage, Crystal Reports OSIsoft Pi), and managing data integrity through system upgrades.
• Coordinate with lab personnel to map out testing processes, perform market research, develop user requirement specifications (URS), and review associated software design specifications or functional specifications, as necessary.
• Develop and maintain system documentation including user requirements specifications (URS), functional specifications, control narratives, configuration details, password management, and backup protocols.
• Participate in commissioning, startup, and qualification activities including factory acceptance testing (FAT), site acceptance testing (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Establish software training for end users coordinating with operations, quality and quality assurance teams including authoring SOPs, creating training resources, and leading classroom training sessions at PBF.
• Lead the setup, configuration, and daily support of LabVantage modules at PBF.
• Ensure systems meet regulatory standards like GxP, 21 CFR Part 11, and data integrity (ALCOA+) principles.
• Support GMP manufacturing activities through adherence to quality systems, change management processes, deviation investigations, and corrective and preventive actions (CAPA).
• Design, implement and document the connections between the LIMS and lab equipment, chromatography data systems, and/or middleware.
• Compliance & Validation: Ensure systems meet regulatory standards like GxP, 21 CFR Part 11, and data integrity (ALCOA+) principles.
• Support engineering facilities, calibrations oversight, and shutdown execution at PBF as required.
• All other duties as required by the supervisor, manager, or program leadership.

Skills

GMP experience

LIMS administration

Data analysis

SQL

Automation systems

Communication skills

Education

Bachelor's degree in Engineering or related

Tools

LabVantage

OSIsoft PI

Crystal Reports

Job description

CAMRIS International, LLC seeks a Lead Systems Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research in Silver Spring, MD. You will lead data integrity tasks, configure automated workflows, and serve as the bridge between bench scientists, QA, and IT infrastructure teams.

Collaborate with process engineers, scientists, operators, maintenance personnel, and vendors to identify automation opportunities and drive efficiencies.