Lead Systems Specialist

CAMRIS•Silver Spring, MD

11d•Onsite

About The Position

We are seeking a Lead Systems Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Requirements

A Bachelor's degree in Engineering, Computer Science, Information Systems, Chemistry, Biology, or a related scientific/technical field.
Understanding of GMP manufacturing practices and regulated computerized systems including data integrity and Good Automated Manufacturing Practice (GAMP) and ICH Q9 (Quality Risk Management).
5+ years working within R&D, MSAT or GMP environments supporting enterprise software or laboratory informatics, with firsthand LIMS administration and/or process automation experience.
Experience with PLCs, DCS, SCADA, HMI systems, instrumentation, and industrial communication frameworks such as OPC-UA.
Strong background in SQL, data analysis, and understanding of lab and clean core (manufacturing) workflows.
Demonstrated oral and written communication with the ability to translate complex lab procedures into logical software requirements using flow-charts, presentations, and good engineering documentation.
Experience managing subcontracted integration resources.

Nice To Haves

Familiarity with SQL databases, OSIsoft, and slocal application data stores associated with research, quality control, and manufacturing equipment.
Data processing skills using R, python, Microsoft Excel, JMP and OSIsoft PI for quality control charting and multifactorial analysis.
AKTA Unicorn method programing and configuration experience.

Responsibilities

Lead data integrity tasks including set up 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.