Sr. Computer Systems Validation Specialist

KBI Biopharma • Durham, NC

1d • Onsite

About The Position

The scope of this role includes supporting all aspects of the Computer Systems Validation (CSV) Lifecycle. The employee will be responsible for the execution and documentation of the CSV Program at the Durham facility. This involves handling implementation tasks, work prioritization, and supporting escalation management activities, all while maintaining the highest level of compliance with regulatory agencies. The employee will also track changes in the regulatory environment and implement processes and procedures to ensure KBI meets ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.

Requirements

• BS or MS in an Engineering or Information Technology discipline
• 5-7 years of industry experience
• Lab equipment validation knowledge and experience is required
• Experience with IT computer validation and alignment of IT validation with other validation requirements is required
• Knowledge of biotech manufacturing obtained from a cGMP facility
• Demonstrated project management ability with good written and oral communication skills is required
• Ability to read, analyze, and interpret complex documents
• Ability to convey information clearly and concisely, both orally and in writing
• Ability to record information, facts, and measurements accurately, clearly, and consistently as required by cGMP, GLP, GCP, and/or by co-workers
• Ability to interface professionally, effectively, and efficiently with all levels of management, coworkers, and outside vendors
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to understand implications of non-compliant results
• Strong attention to detail
• Ability to interpret an extensive variety of technical instructions and prioritize tasks accordingly
• Strong math and analytical skills required
• Ability to apply advanced mathematical concepts such as exponents and algorithms
• Ability to apply mathematical operations to tasks such as frequency distribution, variance analysis, and determination of reliability and validity
• Web applications, spreadsheets, word processing, PowerPoint, and e-mail

Responsibilities

• Complete the execution and documentation of the CSV Program at the Durham facility, including all CSV activities, documentation requirements, and reports such as plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation, and compliance reviews.
• Ensure project deadlines and performance standards for the CSV team are met, communicating status accordingly. Respond to inquiries from management, end users, and clients, and provide frequent status updates.
• Plan, contribute, and collaborate on CSV activities for lab and manufacturing systems.
• Stay current with trends, new products and technologies, and regulatory requirements that may impact CSV. Participate in regulatory and client audits as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior