Job SummaryResponsible 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.
Minimum Requirements: - Bachelor's degree in Engineering or Information Technology discipline. Master's Degree strongly preferred.
- Seven (7) plus years of experience as a CSV Specialist or related role in the pharmaceutical/biotechnology industries.
- Seven (7) years of experience with: GAMP and 21CFR Part 11 compliance requirements and software functional testing; Regulatory guidance documents; Generating concise procedures, protocols, and summary reports; Applying sound validation principles; and Equipment control software.
- Technical Writing; Literacy in CSV lifecycle Documentation review/interpretation; Performing System Risk Assessment for validation testing; Protocol management in development; field execution; deviation resolution and authoring and closure of final reports.
- Understanding of Project Management dynamics and techniques, ability to contribute to project management efforts at the Senior Level with schedule logistics, projections, and resource analysis.
- Subject Matter Expert on KPI reporting process.
- Ability to support internal and external audits.
- Demonstrated ability to effectively lead and train other employees in Validation.
- 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.
