Senior Computer Systems Validation Specialist

KBI Biopharma•Durham, NC

1d•Onsite

About The Position

Support all aspects of the Computer Systems Validation (CSV) Lifecycle. 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. Testing of computer systems in the field including lab, manufacturing, and automation systems. Handwritten execution of computer system validation protocols. Work with Quality Assurance and system owners to resolve deviations that occur during testing activities.

Requirements

Bachelor’s degree or equivalent in computer information systems, computer engineering, computer science, or related field of study and 5 years of progressive experience in the job offered, as a Validation Engineer, Validation Analyst, or related occupation.
Employer will also accept a Master’s degree or equivalent in computer information systems, computer engineering, computer science, or related field of study and 2 years of experience in the job offered as a Validation Engineer, Validation Analyst, or related occupation, in lieu of Bachelor’s degree or equivalent and 5 years of progressive experience.
Employer will accept pre- or post-Master's degree experience. All experience must be post-Bachelor's.
3 years of experience with Project Management dynamics and techniques.
3 years of experience with computer system validation testing, in manufacturing and laboratory settings;
3 years of experience with GAMP and 21CFR Part 11 compliance requirements and software functional testing;
3 years of experience with drafting, reviewing, and approving: validation plans, user requirements specifications, risk assessments, functional requirements specification, configuration specifications, traceability matrices, validation protocols, and periodic reviews;
3 years of experience with MS Office suite, Electronic Document/Info Management Systems, or Engineering software tools;
3 years of experience writing, reviewing and approving quality system documents at a cGMP facility including: change controls, CAPAs, deviations, or validation protocol exception conditions;
3 years of experience performing 3 simultaneous computer system validation projects, including conducting regular validation reviews of computerized systems;
2 years of experience with Biotech manufacturing in a cGMP facility, including GMP gowning practices in cleanrooms and laboratories and 21 C.F.R Parts 210 and 211.
For skills #1 through 7, employer will accept 2 years of experience when qualifying with a Master's degree.

Responsibilities

Support all aspects of the Computer Systems Validation (CSV) Lifecycle.
Complete the execution and documentation of the CSV Program at the Durham facility.
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.
Testing of computer systems in the field including lab, manufacturing, and automation systems.
Handwritten execution of computer system validation protocols.
Work with Quality Assurance and system owners to resolve deviations that occur during testing activities.