Regulated Industry LIMS Developer & Configuration Expert in Houston, TX at Labtopia Inc.

Date Posted: 6/5/2020

Job Snapshot

Job Description



JOB TITLE:  Regulated Industry LIMS Developer & Configuration Expert

Job Type                     Full-Time Salary

Location                      Houston, TX

Travel                          30-50%

JOB SUMMARY

The Regulated Industry LIMS Developer & Configuration Expert is a key position in Labtopia Informatix, Inc. which will report directly to the Director of Operations – Labtopia Informatix.  As a key member of the Labtopia Informatix team, this position will be involved in supporting major implementations of enterprise-wide deployments of Laboratory Information Management System (LIMS) applications and related technology in FDA, EPA and state certified (regulated) industries.  This position will be responsible for the management of all aspects of client projects involving the analysis, design, configuration, integration and maintenance of LIMS systems.  The Regulated Industry LIMS Developer & Configuration Expert is a client-interfacing position which requires a unique combination of computer systems knowledge and understanding of laboratory operations, specifically requirements of FDA/EPA regulated environments.   

Likewise, the Regulated Industry LIMS Developer & Configuration Expert is a key team member in developing additional software applications for laboratory management and compliance.   The Expert will collaborate with members of the company’s development team to design & develop software solutions for QA/QC operations.

The Regulated Industry LIMS Developer & Configuration Expert must be self-directed, highly ethical, energetic, and be able to become familiar with the company's processes and implement improvements where applicable.

RESPONSIBILITIES

  • Analyze business requirements for laboratory processes and transform into software solutions for ThermoFisher Scientific SampleManager LIMS.
  • Programmatically derive complex algorithms for use in analytical and microbiologcal laboratory testing of biomedical, medical device, pharmaceutical and food products.
  • Engineer derivations of USP-NF, JP, EP and other regulatory methodology using configuration and customization tools within LIMS.
  • Customize software applications using C# and proprietary software languages (VGL for Thermo Fisher Scientific SampleManager LIMS).
  • Develop proprietary software applications and modules which extend the basic functionality of SampleManager LIMS to meet regulatory or industry-specific requirements of laboratories.
  • Develop integration tools for the facilitation of data transfer between SampleManager LIMS and in-house (LIMSView) and third-party developed applications.
  • Programmatically integrate laboratory instrumentation databases and file outputs to SampleManager LIMS proprietary database tables for the purpose of the advancement of laboratory automation.
  • Develop custom migration tools to facilitate the migration of historical laboratory data to SampleManager LIMS proprietary database structure.
  • Derive reports and data output files for reporting of data to regulatory agencies, such as FDA, EPA, and state certification bodies based on agency defined criteria.
  • Conduct unit and functional testing of configurations and customizations to confirm requirements are met.
  • Draft documentation, such as technical design documents and application notes, for both technical & non-technical end users.
  • Perform upgrades of existing ThermoFisher Scientific SampleManager LIMS environments to newer software versions, including any migration of existing custom code, using standard and custom-developed release processes.
  • Ensure software applications comply with 21 CFR Part 11 requirements including electronic audit trails and e-signatures, where appropriate.

ORGANIZATIONAL EFFECTIVENESS

  • Provide quality, timely and accurate LIMS analysis / design / configuration / support.
  • Collaborate as part of an implementation team to ensure that the proposed technical design meets the client’s business requirements, desired project objectives and LIMS strategy.
  • Ensure that projects are delivered on time, on budget and to the agreed quality standard.
  • Establishes credibility at all levels with clients and builds problem-solving partnerships with clients and colleagues.
  • Communicate in a clear and timely manner to the customer and project manager on all project milestones and supporting activities.

SALES/BUSINESS DEVELOPMENT

  • Support the business development activities of the company by participating in network events, trade shows and conferences as a company representative.
  • Assist/participate in proposals and demonstrations as a subject matter and technical expert. 

EDUCATION

  • Masters degree in Computer Science, Information Systems, Chemistry, Engineering or related technical field required.  One degree (Bachelor’s or Master’s) must be within Computer Science or IS.

TECHNICAL SKILLS, EXPERIENCE AND ABILITIES

  • Programming languages (C#, C++ for .NET, and .NET 2.0+), experience with SampleManager VGL, object oriented coding highly desired. 
  • SQL database experience required, including ability to write SQL queries and stored procedures; Oracle database experience desirable.
  • Minimum three years of experience in LIMS implementations, preferably with Thermo Fisher SampleManager LIMS.
  • LIMS Integration experience with external systems desirable (instrumentation, chromatography data systems (CDS), enterprise resource planning (ERP) systems, process data systems, Scientific Data Management Systems (SDMS), etc.)
  • Experience in report development using tools such as SampleManager Report Designer, Infomaker, Crystal reports
  • Experience in management of information systems, including development of best practices for windows environments
  • Proficiency with Microsoft Products (Windows, Word, PowerPoint, Visio, Project, and Excel).

ADDITIONAL REQUIREMENTS

  • Experience in FDA and EPA regulated laboratory environments required.
  • Must have excellent written and verbal communication skills to communicate with both clients and coworkers.
  • Effective time management through balancing multiple project responsibilities, ad-hoc customer requests and project-related activities and support.
  • Must be able and willing to work in a dynamic and culturally diverse, team environment across multiple time zones.
  • Possess leadership qualities: Integrity, attention to detail, timeline sensitivity, goal-oriented, motivator, technical/analytical background.
  • Persuasive with details and facts.
  • Ability to write procedures, work instructions, forms and the necessary tasks for Labtopia Informatix.
  • Knowledge of commonly-used concepts, practices, and procedures within laboratories.
  • Employee must be able to pass a background check and drug screen. 
  • U.S. Citizens or Green Card holder highly preferred.  Sponsorship will be considered based on the candidate’s qualifications.
  • Employee must have valid driver’s license.

WORK SCHEDULE

  • M-F, 8am-5pm, flexible hours based on project or work requirements.
  • Must be willing to travel and work overtime as needed to meet client needs
  • Be able to travel up to 50% when necessary.
  • Labtopia is an Equal Opportunity Employer

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