Validation Lead (REMOTE)

The Validation Lead will support the creation, editing, updating, and routing of validation documentation while providing Software Development Lifecycle (SDLC), computer system validation, and regulatory compliance expertise. This role will help define validation strategies for new system implementations and maintain existing systems in an audit-ready, validated state in alignment with corporate and FDA guidance.

Job Title: Validation Lead

Location: REMOTE

Industry: Pharmaceutical / Life Sciences

Job Overview:

The Validation Lead will support the creation, editing, updating, and routing of validation documentation while providing Software Development Lifecycle (SDLC), computer system validation, and regulatory compliance expertise. This role will help define validation strategies for new system implementations and maintain existing systems in an audit-ready, validated state in alignment with corporate and FDA guidance. Preference will be given to candidates with 7+ years of computer system validation experience, especially those with pharma experience.

Responsibilities:

• Create, edit, update, and route validation documents.
• Provide SDLC and validation expertise with regulatory compliance guidance.
• Determine validation strategies for implementing new systems and maintaining existing systems.
• Help keep systems audit ready and in a validated state.
• Write requirements and test scripts, as needed.
• Manage multiple projects and support project implementation in Agile or waterfall environments.
• Support document management, formatting, training, and customer service-related activities.

Requirements:

• Bachelor’s degree in Journalism, English, Communications, Technical Writing, Computer Science, Teaching, Electronics, Education, or a related field.
• 7+ years of computer system validation experience preferred.
• Experience in pharmaceutical, life sciences, or regulated environments.
• Knowledge of GCP, GLP, GMP, 21 CFR Part 11, Computer System Validation (CSV), Quality Assurance (QA), and compliance practices.
• Strong technical writing, document management, training, project implementation, and customer service skills.
• Detail-oriented, resourceful, diplomatic, timely, responsive, trainable, diligent, and honest.
• Required tools: MS Word, MS Excel, and MS Outlook.
• Preferred tools: Jira, Application Lifecycle Management (ALM), MS PowerPoint, Veeva Quality Docs, and ServiceNow.

Best-In-Class-Benefits

We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:

• Robust Health Insurance
• 401(k) plan
• PTO accrual
• Paid holidays
• Excellent cash-based referral program

About Theoris: 

Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.