Sr. Computer Systems Validation Specialist

Position Title: Sr. Computer Systems Validation Specialist (Req#)

Position Location: 1101 Hamlin Road, Durham, NC 27704

* Telecommuting permitted up to 90%. Must live within commutable distance from work location.

Days / Hours: Mon – Fri / 9:00 a.m. – 5:00 p.m.

Job Description: 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.

Qualifications: 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 accept Master’s degree or equivalent in Computer Information Systems, Computer Engineering, Computer Science, or related field of study and 2 years of experience as a Validation Engineer, Validation Analyst, or related occupation, in lieu of Bachelor’s degree and 5 years of progressive experience.

Applicants must have demonstrated experience with:

3 years of experience in the following:

Software development life cycle; End-user using EtQ Reliance, Veeva, Master Control, Documentum or equivalent document management systems to create, review and approve quality documents; Computer system validation testing in manufacturing and laboratory settings; Handwritten execution of computer system validation protocols; Working with Quality Assurance and system owners to resolve deviations that arise during testing activities; and Drafting, reviewing, and approving: validation plans, user requirements specifications, risk assessments, functional requirements specification, configuration specifications, traceability matrices, validation protocols, and periodic reviews.

2 years of experience in the following:

ISPE good automation engineering practices (GAMP) 5, ICH Q7 – Good Manufacturing Practices for APIs, 21 C.F.R. Part 11, and EU Annex 11; Writing, reviewing and approving quality system documents at a cGMP facility including change controls, CAPAs, deviations, and validation protocol exception conditions; and Performing more than two (2) simultaneous computer system validation projects, including conducting regular validation reviews of computerized systems and reviewing audit trails, user access, and system security.

1 year of experience in the following:

Biotech manufacturing at a cGMP facility, including GMP gowning practices in cleanrooms and laboratories and 21 C.F.R Parts 210 and 211; and Validating laboratory and manufacturing equipment, examples including but not limited to HPLCs, CIP skids, filter integrity testers, bioreactors, autoclaves, blood gas analyzers, capillary electrophoresis, and plate readers.

Any and all experience may be gained concurrently. For skills #1 through 6, employer will accept 2 years of experience when qualifying with a Master's degree.

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.

Range: $164,486.00 / yr. - $174,000.00 / yr.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.

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