Sr. Computer Systems Validation Specialist

About the Role

Support all aspects of the Computer Systems Validation (CSV) Lifecycle, including execution and documentation of the CSV Program at the Durham facility. Ensure compliance with regulatory agencies, track changes to the regulatory environment, and implement processes to meet requirements such as 21CFR Part 11, EU Annex 11, and data integrity.

Responsibilities

• Execute and document the CSV Program, including all CSV activities, documentation requirements, and reports (plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation, and compliance reviews). (40%)
• Ensure project deadlines and performance standards for the CSV team are met; communicate status updates to management, end users, and clients. (30%)
• Plan, contribute, and collaborate on CSV activities for lab and manufacturing systems. (25%)
• Stay current on trends, new products, technologies, and regulatory requirements impacting CSV; participate in regulatory and client audits as needed. (5%)

Requirements

• BS or MS in Engineering or Information Technology.
• 5-7 years of industry experience.
• Lab equipment validation knowledge and experience.
• Experience with IT computer validation and alignment with other validation requirements.
• Knowledge of biotech manufacturing from a cGMP facility.
• Demonstrated project management ability with strong written and oral communication skills.

Skills

• Language Ability: Ability to read, analyze, and interpret complex documents; convey information clearly and concisely in writing and orally; record information accurately for cGMP, GLP, GCP compliance; interface professionally with all levels of management, coworkers, and vendors.
• Reasoning Ability: Define problems, collect data, establish facts, and draw valid conclusions; strong attention to detail; interpret technical instructions and prioritize tasks.
• Math Ability: Apply advanced mathematical concepts (e.g., exponents, algorithms) and operations (e.g., frequency distribution, variance analysis, reliability/validity determination).
• Computer Skills: Proficiency in web applications, spreadsheets, word processing, PowerPoint, and email.

Physical Demands

• Ability to walk and stand for protocol execution and system evaluations.
• Ability to lift, carry, push, and pull computer hardware as needed.

Equipment Use

• Computer, telephone, copier/printer.