Validation Consultant for Lab Informatics

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’s 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 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, industry, IT, and regulatory expertise.

Our Culture

Demands and rewards Excellence. We promote an environment that is dynamic, fun, and encourages creativity. We have been voted a Top Workplace consecutively since 2014. The ideal candidate will share our culture of personal growth, shared accountability, and solid work ethics.

Our Clients’ Success

Is our main objective. All CSols employees share this passion for delivering excellence and become the client’s advocate for success.    

Job Description

We are adding an Informatics Validation and Strategic Services Consultant to our staff. In this position you will work with the validation and strategic services teams to carry out multiple tasks, some that overlap.

When not working with a client on lab informatics system validations, you may work with other clients to plan new system implementations by helping them to gather accurate lab needs or select a vendor by writing RFPs and setting up vendor demos. You will act as the guide to the client, taking them step by step through the selection process and acting as their advocate to ensure they get exactly what they need from their informatics software purchase.

Job roles will include the following:

• Perform various validation activities for GxP laboratory systems including, but not limited to, LIMS, CDS, ELN, LES, and various laboratory instruments
• Develop and execute validation deliverables including, but not limited to, Gap Analysis, Risk Assessments, Validation Plan, IQ, OQ, PQ, IV, FV, UAT scripts and testing, Validation Summary Reports, and Requirements Traceability Matrix
• Attend daily, weekly, and monthly meetings on projects and interface directly with customers and other teams
• Manage day to day schedule and timelines for deliverables
• Assist CSols colleagues with validation strategy and tactics
• Assist the Strategic Services team with the development of laboratory workflows, demonstrations scripts, and reports for clients

Desired Qualifications

Critical skills for success in this position include:

• Experience in the validation of GxP Laboratory systems; experience validating GxP manufacturing is also a plus
• Ability to quickly grasp clients’ high-level business drivers
• Ability to quickly understand the day-to-day process drivers at the lab analyst and lab management levels
• Strong understanding of laboratory workflows in order to efficiently communicate with a broad range of client laboratory subject matter experts
• Excellent presentation and verbal communication skills with broad audiences (from entry-level analysts to executives) in one-on-one and large group settings
• Capability to extrapolate current business processes to an improved state via the application of best practices and laboratory informatics
• Ability to produce quality, time-sensitive deliverables for multiple parallel projects independently or with a team remotely or onsite
• A deadline-focused approach that is self-motivated and self-directed
• Willingness to share ideas with and accept new ideas from internal and client teams
• Personal accountability and a desire to strive for excellence at all times

Education Preferences:

• Bachelor’s degree or higher in a laboratory science (e.g., chemistry, biology, microbiology, pharmacology, immunology)

Or

• Bachelor’s degree or higher in computer science with a joint background in laboratory sciences

Or

• Bachelor’s degree or higher in business with minor or additional degree in a laboratory science

Required Experience:

• Hands-on experience with at least one specific major laboratory informatics system or vendor (e.g., LabWare/LabVantage/SampleManager LIMS, Empower, BIOVIA, PerkinElmer ELN)
• At least five years of validation for laboratory systems
• At least five years of business and/or laboratory experience within a regulated laboratory environment
• Experience in a laboratory equipment or lab software implementations

Preferred Experience:

• The candidate should have hands-on experience with at least one other type of laboratory informatics system or vendor (e.g., LIMS, CDS, SDMS, ERP/MRP, other applicable support systems)
• At least 5 years of experience working in a GxP laboratory
• At least 5 years of experience in validation of laboratory informatics systems and projects

Benefits Overview

CSols has been voted a Top Work Place in Delaware from 2014 to 2021. 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.

Covid Message: We value the safety and well-being of our CSols community, which includes our staff, customers, business partners, and beyond. This is why our team has chosen to require staff to be fully vaccinated, whether that be on-site at our corporate office or traveling for business. Candidates should consider this requirement before applying.

Some Travel is required for this position.  CSols support flexible work environments enabling office and home-based employees.