LIMS Validation Documentation Specialist(LAB INFORMATION MGMT SPECIALIST)

Overview

Remote
$60 - $65
Contract - W2
Contract - Independent
Contract - 12 Month(s)
No Travel Required

Skills

LabWare
LabVantage
LIMS

Job Details

Job Title: LIMS Validation Documentation Specialist (LAB INFORMATION MGMT SPECIALIST)

Location: Greater Boston, MA (Remote)

REMOTE

Exp: 8+yrs

Any Visa Type

About the Role:

We are seeking a detail-oriented LIMS Validation Documentation Specialist to support the validation of a Laboratory Information Management System (LIMS) implementation for a leading biotech organization. This role will focus on authoring and managing validation documentation in compliance with GxP and FDA regulatory requirements.

Qualifications:

3+ years of experience in validation documentation within biotech, pharma, or life sciences.

Strong understanding of GxP, 21 CFR Part 11, and CSV (Computer System Validation) principles.

Experience supporting LIMS or other regulated system implementations.

Excellent technical writing and organizational skills.

Familiarity with tools such as Veeva Vault, MasterControl, or similar document management systems is a plus.

Preferred:

Bachelor s degree in Life Sciences, Computer Science, or related field.

Experience with LabWare, LabVantage, or similar LIMS platforms.

Key Responsibilities:

Develop and maintain validation documentation including:

Validation Plans (VP)

User Requirements Specifications (URS)

Functional Requirements Specifications (FRS)

Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols

Traceability Matrices

Summary Reports

Collaborate with QA, IT, and business stakeholders to ensure documentation aligns with regulatory and internal quality standards.

Support execution and review of validation protocols.

Assist in audit preparation and respond to documentation-related queries.

Ensure documentation is version-controlled and archived per company SOPs.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.