Computer System Validation

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 allocates a portion of our profits to helping those less fortunate.

We provide the expertise and services required to plan, implement, integrate, and validate the 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, your specific industry, IT, and regulatory expertise.

Our Culture

Demands and facilitates Excellence. We have been voted a Top Workplace each of the last four years.

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 CDS Validation Consultant to our Software Validation team. In this detail-oriented role, you must be: conversant with the use of chromatography systems 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 a Laboratory Science(Biology, Chemistry, or Microbiology), or Computer Science with a colligate background in laboratory sciences or 5-10 years of experience validating software in an FDA, GxP regulated environment.
  • Experience validating current versions of CDS software such as Empower or Agilent OpenLAB (CDS, ChemStation, EZChrom).
  • 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 – 2017. Our company culture is founded on four foundations (Excellence, Teamwork, Sustainability & Scalability and Customer Satisfaction). Layered on that are our 3 key principles related to people (Work / Life Balance, Shared Accountability and Personal Ethics).

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 both the growth of 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 enabling office and home-based employees.