Computer System Validation Csv Remote Jobs in Pennsylvania

This job is posted in multiple locations. When not at a client site, consultants work from their home office. Relocation is not required.

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a LIMS Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You'll Do

As a LIMS Consultant at Clarkston you will:

• 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

How You'll Grow
Beyond your day-to-day responsibilities, throughout your career at Clarkston you will:

• Receive the support and mentorship of your Clarkston colleagues and leaders
• Expand your existing skillset with internal and external professional development opportunities

Requirements

What We're Looking For:

• 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

Travel Requirement
Travel is an integral part of this role and is estimated to average 30-50%. This may vary based upon client and project needs. When not traveling, consultants work from their home office. Relocation is not required.

More About Clarkston

Founded in 1991, Clarkston Consulting delivers technology and management solutions to market leaders in the life sciences, consumer products, and retail industries. At Clarkston, we cultivate success - for our clients, for our people, and for our firm. We utilize a team approach leveraging our collective expertise and industry knowledge to solve our clients' business challenges.

AI Statement

Clarkston values thoughtful and responsible AI use for resume writing, interview preparation, and research. However, real-time use of AI to generate or script answers during interviews - including video or live conversations - is strictly prohibited and will lead to disqualification. We seek candidates who show authenticity, good judgment, and genuine engagement throughout the process.

Benefits

Our benefits include:

• 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, and more

We strive to ensure that every candidate has an equitable and accessible experience. If you are selected to move forward in the interview process, we will share information about how to request any accommodations. You may also request support at any point during the hiring process.

Visit Careers at Clarkston to learn more about our culture, benefits, and opportunities.

Clarkston Consulting is an equal opportunity employer. We are committed to ensuring our firm is rich in diverse skills, competencies, strengths, personalities, and culture. We foster an inclusive environment that embraces the unique contributions of our people to further our purpose. Please visit Diversity @ Clarkston to learn more about our diversity initiatives.