LIMS Validation Consultant
Company Overview
CSols, Inc. has become the premier Laboratory Informatics Consultancy in North America by earning and maintaining a reputation for excellence in everything we do. All CSols’ relationships with employees, clients, and partners are characterized by integrity, quality, and high value. We are committed to making our world a better place and allocate a portion of our profits to helping those less fortunate.
We provide the expertise and services required to plan, implement, integrate, and validate industry-leading laboratory informatics solutions faster and better than you could do otherwise. We are the experts!
Our People: Have on average >10 years of experience with leading Laboratory Informatics products, scientific domain knowledge, industry, IT, and regulatory expertise.
Our Culture: Demands and Rewards Excellence. We promote an environment that is dynamic, fun and encourages creativity.
Your Success: Is our only objective. This means optimized lab informatics solutions delivered on time, on budget, meeting requirements, and with industry-leading lab informatics solution adoption rates.
Job Description
We are looking to add a LIMS Validation Consultant. In this detail oriented role, you must be: conversant with the use of LIMS in an FDA regulated environment, QC and R&D laboratory operations, and industry best practices for validating software. This understanding will provide a basis from which the candidate can work with laboratory, QA, and IT personnel to lead validation projects and create validation lifecycle documentation, including
- User and Functional Requirements and Specifications
- Validation Plan
- Risk Assessments (e.g., functional, Part 11, design, etc.)
- IQ/OQ/PQ Testing
- Configuration Specifications
- Trace Matrices
- Validation Summary Report
We will provide the proper training for the qualified candidate in order to secure their success within our growing organization.
Desired Qualifications
The ideal candidate will be a detail oriented team player with excellent communication skills as well as the ability to work well under pressure and meet deadlines in a timely fashion. Also, they must have the ability to work remotely and independently with little to no supervision. They must be a motivated self-starter and possess the following abilities, experience, and knowledge:
- Bachelor’s degree in Laboratory Science (Biology, Chemistry, or Microbiology), or Computer Science with a collegiate background in laboratory sciences, or 5-10 years of experience validating software in an FDA, GxP regulated environment.
- Experience validating current versions of LIMS systems such as LabVantage, SampleManager, LabWare, or STARLiMS.
- Strong understanding of Good Documentation Practices, Computer System Validation (e.g., GAMP 5), and the software development lifecycle
- Ability to explain problems and solution alternatives to IT project and business teams ∙ Ability to work within a team setting as well as alone
Benefits Overview
CSols has been voted a Top Work Place in Delaware from 2014 – 2019. Our company culture is founded on eight Core Values: Team Player, Strong Work Ethic, Smart, Excellence, Accountable, Professional, Humble, and Integrity.
Our commitment to our employees’ success is supported by:
- Competitive pay and bonus structure
- Extensive healthcare plan(s) for you and your family
- Vision plan
- Dental plan
- 401(k), including mandatory company 3% contribution annually
- Company-paid life insurance
- Company paid short and long-term disability insurance
- Generous paid time off
- Comprehensive training and career planning
CSols, Inc. works to maintain a culture of excellence in everything that we do through teamwork, allowing us to exceed what any one of us could do individually. At CSols, all decisions are driven by long-term sustainability and our desire to facilitate the growth of both the company and our employees. We provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, success, and culture.
Travel is required for this position. CSols supports flexible work environments that enable office- and home-based employees to work together.