Sr. Computer Systems Validation Specialist

KBI Biopharma; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks a CSV professional to support the entire CSV lifecycle at the Durham facility.

You will execute and document CSV activities, generate plans, risk assessments, validation protocols, and ensure compliance with regulatory requirements including 21 CFR Part 11, EU Annex 11 and data integrity. The role requires 5-7 years in the field, lab equipment validation experience, IT validation alignment, and strong project management and communication skills.

Qualifications

• 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.

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.
• 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.
• Plan, contribute and collaborate on CSV activities for lab and manufacturing systems.
• 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.

Skills

Project management

cGMP knowledge

IT validation

Lab equipment validation

Regulatory compliance

Written and oral communication

Education

BS or MS in Engineering or IT

Tools

PowerPoint

Spreadsheets

Word processing

Email

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.