Overview:

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.

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.

Qualifications:

• 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.

Preferred Qualifications

• 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.

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

• Occasionally conduct sedentary work that primarily involves sitting/standing.
• Occasionally conduct light work that includes moving objects up to 20 pounds.
• Rarely conduct medium work that includes moving objects up to 50 pounds.
• Rarely conduct heavy work that includes moving objects up to 100 pounds.
• Rarely conduct very heavy work that includes moving objects over 100 pounds.
• Occasionally push or pull less than 25 pounds.
• Rarely push or pull 25 - 45 pounds.
• Rarely push or pull more than 45 pounds.
• Rarely reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes.
• Occasionally bend, reach, or twist repeatedly.
• Occasionally kneel, squat, or stoop.
• Rarely crawl or climb.
• Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Rarely ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
• Rarely move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Occasionally work in low temperatures.
• Occasionally work in high temperatures.
• Rarely work in outdoor elements, such as precipitation and wind.
• Occasionally work in noisy environments.
• Rarely work in small and/or enclosed spaces.

PPE and Chemical Requirements

• Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Occasionally wear a lab coat.
• Rarely wear earplugs/muffs.
• Occasionally work in a Clean Room Uniform.
• Occasionally wear a disposable dust/surgical mask.
• Rarely wear a respirator, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.

Other:

• Sitting/standing should be managed.
• Extended screen time is expected.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.