Sr/Principle Computer Systems Validation Specialist

KBI Biopharma•USA - NC - Remote, NC

4d•Onsite

About The Position

This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technical expertise for all global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.

Requirements

Experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment.
Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as current regulatory guidance on Data Integrity.

Responsibilities

Provide oversight of enterprise software validation from a global perspective.
Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.
Provide oversight and management to validation managed services for associated projects.
Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.
Provide support for data integrity global initiatives.
Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software.