CSV Specialist II

About the role

Supports 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 includes 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.

Executes on implementation tasks, works on prioritization and supports escalation management activities while ensuring the highest level of compliance with regulatory agencies. Tracks changes to the regulatory environment and implements processes and procedures enabling KBI to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.

Maintains and accesses the validation documentation archive to fulfill internal/external client and/or auditor requests. Coordinates validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.

Responsibilities

• Author protocols, test scripts, and data tables for validation studies
• Conduct expert data analysis/verification and prepare summary reports
• Manage implementation tasks and prioritize work
• Support escalation management activities
• Track regulatory changes and implement necessary processes
• Maintain and access validation documentation archive
• Coordinate validation support for Quality Event processes

Requirements

• Bachelor’s degree in Engineering, Information Technology, or a related discipline
• Minimum of 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
• Familiarity with the CSV lifecycle, including system risk assessment, protocol development and execution, deviation management, and final report authoring
• Working knowledge of equipment control software and validation principles
• Working knowledge of reading and interpreting 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
• Basic mathematical and data analysis skills to support validation activities
• Strong organizational, time management, and multitasking skills, with a focus on delivering high-quality, compliant documentation
• Ability to work effectively both independently and within a team environment
• Capable of meeting minimal physical requirements, including lifting up to 25 lbs

Qualifications

• 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
• Minimum of 3 years of hands-on experience with validation documentation, including procedures, protocols, risk assessments, and summary reports
• Minimum of 3 years of hands-on experience with equipment control software and validation principles
• Minimum of 3 years of hands-on experience with reading and interpreting technical documentation (e.g., P&IDs, engineering specifications, SOPs, and batch records)
• Minimum of 3 years of hands-on experience with Microsoft Office applications (particularly Excel) and electronic document management systems
• Minimum of 3 years of hands-on experience with basic mathematical and data analysis skills to support validation activities
• Minimum of 3 years of hands-on experience with organizational, time management, and multitasking skills, with a focus on delivering high-quality, compliant documentation
• Minimum of 3 years of hands-on experience with working effectively both independently and within a team environment
• Minimum of 3 years of hands-on experience with meeting minimal physical requirements, including lifting up to 25 lbs

Skills

• Technical writing and communication skills
• Data analysis and problem-solving abilities
• Microsoft Office proficiency
• Technical documentation interpretation
• Regulatory compliance understanding

Benefits

N/A

Pay

N/A

Schedule

N/A