What are the responsibilities and job description for the Computer Systems Validation Specialist position at KBI Biopharma?
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.
This is a hybrid position, with travel to Durham Hamlin Road facility as needed.
Experience :
- BS or MS in an Engineering or Information Technology discipline
- 3 - 5 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 a cGMP facility
- Good written and oral communication skills is required
