CSV Specialist II

KBI Biopharma • Durham, NC

6d

About The Position

Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use. This will include authoring of protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for systems and re-qualifications. Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies. Employee will track changes to the regulatory environment and implement processes and procedures enabling KBI to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity. The role will also be generally responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests. In addition, there will be tasks related to coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.

Requirements

• Bachelor’s degree in Engineering, Information Technology, or a related discipline.
• 3–5 years of experience as a CSV Specialist or in a comparable role within the pharmaceutical or biotechnology industry.
• Minimum of 3 years of hands-on experience with GAMP and 21 CFR Part 11 compliance, including software functional testing and application of regulatory guidance.
• Demonstrated experience in developing and reviewing validation documentation, including procedures, protocols, risk assessments, and summary reports.
• Working knowledge of the CSV lifecycle, including system risk assessment, protocol development and execution, deviation management, and final report authoring.
• Familiarity with equipment control software and validation principles.
• Ability to read and interpret technical documentation (e.g., P&IDs, engineering specifications, SOPs, and batch records).
• Strong technical writing and communication skills, with the ability to present effectively to internal stakeholders.
• Proven problem-solving and critical thinking abilities, with capability to analyze data and apply sound judgment in non-standard situations.
• Proficiency in Microsoft Office applications (particularly Excel) and electronic document management systems.
• Strong organizational, time management, and multitasking skills, with a focus on delivering high-quality, compliant documentation.
• Basic mathematical and data analysis skills to support validation activities.
• Ability to work effectively both independently and within a team environment.
• Capable of meeting minimal physical requirements, including lifting up to 25 lbs.

Responsibilities

• Authoring of protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for systems and re-qualifications.
• Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
• Track changes to the regulatory environment and implement processes and procedures enabling KBI to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.
• Maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests.
• Coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.

What This Job Offers

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