LIMS Consultant

Summary

Clarkston Consulting is a consulting firm delivering business and technology solutions to clients in the life sciences, consumer products, and retail industries. The LIMS Consultant will configure, customize, validate, and automate laboratory information management system workflows while collaborating with scientists, quality teams, IT, and clients on regulated system implementations.

Responsibilities

• Configure LIMS modules to support workflows, including assay development, plate results, sample management, stability, and analytical testing processes
• Design, configure, and validate assay workflows within, ensuring alignment with scientific requirements and regulated (GxP) environments
• Develop and maintain scripts for workflow automation, business rules, calculations, instrument integration, and data transformation within LIMS
• Develop project documentation and conduct demos of configuration to clients
• Collaborate with scientists, QA/CSV teams, and IT to gather requirements, design technical solutions, and support system validation activities (URS, FRS, DS, IQ/OQ/PQ)
• Ensure configurations comply with 21 CFR Part 11 and other validation procedure
• Collaborate with a team of LIMS consultants working across various sites for LIMS deployment
• Receive the support and mentorship of your Clarkston colleagues and leaders
• Expand your existing skillset with internal and external professional development opportunities

Skills

• Minimum of 2 years of hands-on experience working with LabWare or LabVantage LIMS
• Experience configuring and customizing LabWare or LabVantage LIMS to support laboratory workflows
• Proven ability to design, configure, and validate assay workflows
• Experience developing and maintaining scripts for workflow automation, business rules, calculations, instrument integrations, and data transformations
• Solid understanding of laboratory operations and end-to-end lab processes
• Proficient in developing comprehensive project documentation and delivering configuration demonstrations to clients
• Excellent attention to detail with strong analytical and problem-solving skills
• Effective communication and collaboration skills, with the ability to work across cross-functional teams
• Experience working in regulated environments such as pharmaceuticals, biotechnology, or food safety
• Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements
• 4-year degree in Life Sciences, Information Technology, or a related discipline

Qualifications

Must Haves

• Minimum of 2 years of hands-on experience working with LabWare or LabVantage LIMS
• Experience configuring and customizing LabWare or LabVantage LIMS to support laboratory workflows
• Proven ability to design, configure, and validate assay workflows
• Experience developing and maintaining scripts for workflow automation, business rules, calculations, instrument integrations, and data transformations
• Solid understanding of laboratory operations and end-to-end lab processes
• Proficient in developing comprehensive project documentation and delivering configuration demonstrations to clients
• Excellent attention to detail with strong analytical and problem-solving skills
• Effective communication and collaboration skills, with the ability to work across cross-functional teams
• Experience working in regulated environments such as pharmaceuticals, biotechnology, or food safety
• Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements
• 4-year degree in Life Sciences, Information Technology, or a related discipline

Benefits

• Comprehensive Health and Wellness Benefits (Medical, Dental, Vision, and more)
• 401k with company contributions
• Paid vacation, personal days, holidays, and sick leave
• Paid Parental Leave and Family Building Benefits (Adoption, Surrogacy, and Infertility Support)
• Life and Disability Insurance
• Training and Professional Development investments
• Tuition Assistance
• Receive the support and mentorship of Clarkston colleagues and leaders
• When not at a client site, consultants work from their home office