Position: Computer Validation Specialist (CSV)

FLSA Status: Exempt

Role Overview

As a Computer Validation Specialist (CSV), you’ll play a key role in ensuring the quality of our processes by coordinating validation efforts for computer systems, hardware, and software, especially in a lab setting. Your expertise will help maintain the integrity of our systems while ensuring they meet compliance standards. You’ll be involved in creating validation plans, managing project activities, and developing protocols, all while supporting continuous improvement initiatives. This role does not have supervisory responsibilities but will give you the opportunity to collaborate across various teams, providing technical expertise and guidance.

Key Responsibilities

Collaborate with QA management to develop and implement an efficient software/computer validation program for a GLP (Good Laboratory Practice) environment.
Identify validation needs for computerized systems through in-house assessments or by working with external teams.
Partner with business and validation teams to manage site computer validation projects.
Develop software/computer validation protocols and final reports, and coordinate and perform validation activities according to these protocols.
Maintain the site’s Master Validation Schedule and oversee the periodic review of validated systems.
Assist QA in auditing vendors for cGMP-related software and hardware to ensure compliance.
Evaluate vendor validations, and where necessary, add company-specific protocols to complete the validation process.
Provide technical expertise on validation plans and protocol designs, offering input on specification requirements for equipment, facilities, and systems.
Train team members on relevant SOPs to ensure company-wide understanding of validation processes.
Support additional responsibilities as needed.
Qualifications

Bachelor’s degree or equivalent experience is required.
5-10 years of experience in Computer System Validations is preferred.
Strong understanding of GxP (Good Practice) and federal regulations related to information technology.
Knowledge of GLP (21 CFR Part 11) and other compliance frameworks.
Advanced understanding of laboratory operations and data collection.
Ability to work effectively under time constraints and manage multiple projects simultaneously.
Behavioral Competencies

Adaptability and flexibility in changing environments.
Conflict resolution and problem-solving skills.
Critical thinking and the ability to anticipate challenges.
Resilience and a positive approach to overcoming obstacles.
Special Requirements

This role will be based approximately 80% in an office setting and 20% in a laboratory, with potential exposure to animal pathogens, chemicals, and zoonotic organisms.
Must be able to wear personal protective gear, including N95 masks and respirators, when required.
Physical requirements include the ability to lift and carry up to 50 lbs, as well as occasionally climbing ladders and stairs.
Flexibility to work beyond a typical work schedule, including evenings, weekends, and extended shifts with short notice when necessary.