KBI Biopharma
CSV Specialist II
USA - NC - Durham - National Way · Mid
Sponsorship not specifiedDetected 102 days ago
Data AnalysisExcelManual TestingCommunicationProblem SolvingCritical ThinkingTime ManagementWritingMicrosoft Office
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About the role
- 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.
- The role will also be generally responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests.
- KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
Responsibilities
- 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.
- 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.
- 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.
- Ability to work effectively both independently and within a team environment.
Company info
- I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.