Senior Computer Systems Validation Specialist

KBI Biopharma, Inc.; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior CSV Specialist to support the Computer Systems Validation lifecycle, author protocols, test scripts, and data analyses to ensure qualification for use. You will track regulatory changes and help prepare summary reports for audits.

The role requires 7+ years in CSV or related roles in pharma/biotech, strong technical writing, and the ability to lead validation efforts, coordinate with QA, and support Change Controls and CAPAs.

Qualifications

• Bachelor’s degree in Engineering or IT
• Seven (7) plus years of CSV experience in pharma/biotech
• Experience with 21 CFR Part 11 and GAMP guidance
• Strong technical writing and data analysis skills

Responsibilities

• Support CSV lifecycle for validation projects including protocol authoring
• Conduct data analysis and prepare summary reports for validation conclusions
• Coordinate validation efforts with QA, Change Controls, Deviations, CAPAs and audits

Skills

CSV lifecycle

Regulatory compliance

Technical writing

Data analysis

GAMP 21 CFR Part 11

Project coordination

Education

Bachelor’s degree in Engineering or IT

Master’s degree preferred

Tools

Microsoft Office (Excel)

Electronic document management systems

Job description

Job Summary 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 fulfil 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.
• 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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

• We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.
• At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.

Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.