CSols is an internationally acclaimed Laboratory Informatics company. We provide the expertise and services required to implement, integrate and validate laboratory informatics systems. To create optimum software solutions we uniquely combine:
- Superior domain expertise
- Pharmaceutical, Biotech, Medical Device, Chemical, Petrochemical, Energy, Mining, Food & Beverage, Environmental, and Government
- A high caliber staff of Scientists, IT Experts, and Regulatory Specialists
- Comprehensive services and product portfolios, and
- Flexible & adaptive business and implementation processes
CSols has been a leader in this market sector since 1990, 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.
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-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 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 has been voted to the Top Work Places in Delaware for 2014, 2015, 2016 and is recognized for our work/life balance approach. We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive pay and an extensive healthcare plan, 401(k), long-term and short-term disability, life insurance, paid holidays, and an excellent career path. Plus, 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.
If you are interested please email resumes to firstname.lastname@example.org and include the job title in the subject line.