Job Description

We are seeking an onsite LIMS LabVantage Engineer to provide onsite support at 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 diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Note: This role is based onsite at WRAIR PBF in Silver Spring, MD.

• Leads LIMS implementation and expansion, ensuring adherence to project timelines and budgets.
• Collaborates with stakeholders to gather requirements and design effective LIMS solutions.
• Configures LabVantage to meet specific business needs, including workflows, security settings, and reporting.
• Oversees the creation, maintenance, and accuracy of master data within the LIMS system.
• Customizes and configures LabVantage modules, workflows, and reports to fit the laboratory's unique requirements.
• Develops and implements data governance policies and procedures.
• Ensures data integrity and consistency across the organization.
• Provides end-user support for quality control activities, including data validation, review, and approval processes.
• Assists in the development and implementation of quality control standards and procedures.
• Monitors and troubleshoots quality control issues.
• Performs routine maintenance, updates, and upgrades to the LabVantage LIMS to ensure optimal performance and reliability.
• Manage project management scrum and coding sprints, ensuring efficient and effective delivery of LIMS projects.
• Facilitates team meetings, tracks progress, and identifies potential risk and mitigation strategies.
• Coordinates with cross-functional teams to ensure project success.
• Provides technical support to end-users, resolving issues and answering questions related to LabVantage functionality.
• Maintains and updates LIMS documentation and training materials.
• Stays current with the latest LabVantage updates and best practices.
• Manages application vendor support agreements.
• Oversees other IT, Engineering, and ESM applications as required by management.
• Escorts subcontractors at the facility, ensures they follow site policies, and verifies they complete tasks assigned.

Required

• Bachelor's degree in Engineering, Information Technology, or a related field and ten (10) years of relevant experience
• Minimum of five (5) years of experience in LabVantage 8 LIMS coding, development, and implementation.
• GMP Quality Control, Environmental Monitoring, or Manufacturing experience.
• Experience in QC GMP environments and understanding of laboratory workflows.
• Strong understanding of LIMS implementation methodologies and best practices.
• Familiarity with LabVantage LIMS architecture and database schema.
• Proven experience in managing project management scrum and coding sprints.
• Excellent problem-solving and troubleshooting skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non-US citizen.

Preferred

• Engineering background and experience with external integrators.
• Certifications in LabVantage or related LIMS technologies.
• Experience with computer system validation (CSV).
• Experience with Factory Talk and QC hardware data acquisition.
• Experience with other GMP or biopharmaceutical software applications.

Please submit your resume online at CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Our offerings include medical, dental, and vision insurance, FSAs and HSA, life and disability coverage, retirement plans with employer match, tuition reimbursement, public transportation support in the DMV area, and generous paid time off. Additional benefits include legal services, pet insurance, and an employee referral bonus program.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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