We are currently looking to add a Senior Validation Consultant to our Software Validation team. In this detail oriented role, you must be: conversant with the use of laboratory software in an FDA regulated environment, 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 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 Reports
We will provide the proper training for the qualified candidate in order to secure their success within our growing organization.
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-started and possess the following abilities, experience, and knowledge:
- Bachelor’s degree in a Laboratory Science (Biology, Chemistry, or Microbiology), or Computer Science with a collegiate background in laboratory sciences, or 7-10 years of experience validating laboratory software systems in an FDA, GxP regulated environment.
- Experience with laboratory COTS systems such as: Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), standard benchtop laboratory software systems.
- 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
CSols is an internationally acclaimed Laboratory Informatics company. We provide the expertise, services and products required to implement, integrate and validate laboratory informatics systems to create optimum software solutions. CSols, Inc. is a unique working environment listed on Delaware’s Top Workplaces several years in a row that provides:
- Competitive Compensation
- Positive Work/Life Balance
- Health, Dental, Vision, and Life Insurances
- 401(k) with company contribution
- Attractive PTO package
We work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture. Travel is required for this position.
CSols Inc has been a leader in this market sector since 2001, and has offices in the US and Canada. We have been able to grow for the last several years at double digit rates due to our focus on our customers’ success.
CSols Inc shall be recognized as the premier Laboratory Informatics Consultancy in North America by earning and maintaining a reputation for excellence in everything we do.
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