Sr/Principle Computer Systems Validation Specialist

KBI Biopharma Inc.; Durham (NC); On-site; USD 118,000 - 162,800; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid PTO and holidays

Sabbatical program

401K matching with 100% vesting in 60 days

Employee recognition programs

Job summary

KBI Biopharma Inc. is looking for a Sr/Principal Computer Systems Validation Specialist in Durham, NC. This individual will oversee enterprise software validation in a cGMP environment, providing expert guidance on validation lifecycle deliverables and ensuring compliance with regulatory standards. Candidates need substantial experience in Data Integrity and FDA regulations. The salary range is competitive, with additional benefits including annual bonuses and full medical coverage.

Qualifications

• 15+ years for Principal, 8+ years for Senior in computer systems validation.
• Demonstrated expert knowledge of current regulatory guidance on Data Integrity.

Responsibilities

• Provide oversight of enterprise software validation from a global perspective.
• Review and approve validation lifecycle deliverables for enterprise software.
• Manage validation services and ensure compliance with regulatory requirements.

Skills

cGMP environment experience

Data Integrity expertise

Knowledge of 21CFR Part 11

Experience in FDA regulated manufacturing

Education

BS/MS degree

Job description

## Sr/Principle Computer Systems Validation SpecialistApplylocations: USA - NC - Remotetime type: Full timeposted on: Posted Yesterdayjob requisition id: R00008270Job DescriptionThis 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. Job 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 This position will be based in Durham, NC and will require a regular site presence. Minimum Requirements:* (Principal - BS/MS and 15+ years/ Senior - BS/MS and 8+ years) 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. Salary Range:$118,000 - $162,800 (Senior)$133,000 - $183,700 (Principal)Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.*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.*