Sr. Computer Systems Validation Specialist

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a CSV Specialist to support the Computer Systems Validation lifecycle at its Durham, NC facility.

The role focuses on executing and documenting CSV activities, including plans, risk assessments, validation protocols, and traceability matrices to ensure compliance with 21 CFR Part 11 and related standards. The successful candidate will manage CSV tasks, communicate status to management and clients, and stay updated on regulatory changes affecting CSV programs.

Qualifications

• BS or MS in Engineering or Information Technology.
• 5–7 years of industry experience.
• Lab equipment validation knowledge and experience required.
• Experience with IT computer validation and aligning IT validation with other validation requirements.
• Biotech manufacturing knowledge from a cGMP facility.

Responsibilities

• Execute and document the CSV program at the Durham facility, including plans, risk assessments, test protocols and validation reports.
• Manage CSV team tasks to meet project deadlines and provide status updates to stakeholders.
• Plan and collaborate on CSV activities for lab and manufacturing systems.
• Stay current with regulatory trends and participate in audits as needed.

Skills

Lab equipment validation

IT validation

cGMP biotech knowledge

Project management

Communication

Attention to detail

Education

BS or MS in Engineering or IT

Job description

Job Summary

Scope will include supporting all aspects of the Computer Systems Validation (CSV) Lifecycle. Employee will complete the execution and documentation of the CSV Program at the Durham facility. Employee will 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.

Job Responsibilities

• Complete the execution and documentation of the CSV Program at the Durham facility. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews. (40%)
• Ensure project deadlines and performance standards for the CSV team are met while communicating status accordingly; Respond to inquiries from management, end users and clients, and provide status updates on a frequent basis. (30%)
• Plan, contribute and collaborate on CSV activities for lab and manufacturing systems. (25%)
• Keep current of trends, new products and technologies, and regulatory requirements that may have an impact on CSV. Participate in regulatory and client audits as needed. (5%)

Minimum Requirements

Experience:

• BS or MS in an Engineering or Information Technology discipline
• 5-7 years of industry experience
• Lab equipment validation knowledge and experience is required
• Experience with IT computer validation and alignment of IT validation with other validation requirements is required.
• Knowledge of biotech manufacturing obtained from cGMP facility
• Demonstrated project management ability with good written and oral communication skills is required.

Language Ability: Ability to read, analyze, and interpret complex documents. Conveys information clearly and concisely, both orally and in writing. Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers in order to understand situations and to perform their assignments. Interfaces professionally, effectively, and efficiently with all levels of management, coworkers, and outside vendors. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Understands implications of non-compliant results. Strong attention to detail. Ability to interpret an extensive variety of technical instructions and prioritize tasks accordingly. Math Ability: Strong math and analytical skills required. Ability to apply advanced mathematical concepts such as exponents and algorithms. Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.

Physical Demands: Ability to walk and stand in order to perform and assist in performance of protocol execution and computer system evaluations. Ability to lift, carry, push and pull computer hardware when needed. Computer Skills: Web applications, spreadsheets, word processing, PowerPoint, and e-mail Equipment Use: Computer, telephone, copier/printer

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.

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. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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.