Position Location: 47 National Way, Durham NC 27703

Telecommuting permitted up to 20% of the week.

Travel: 10% domestic travel required

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

Summary of Duties: Coordinate and execute validation studies, write protocols, document results, and generate final reports and summaries of work for release of equipment tested. Develop and revise new and existing procedures to ensure compliance to cGMP, GLP, and regulatory requirements. Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, Impact Assessments, and other Quality Systems. Provide technical advice on new equipment and modification to existing equipment to ensure validation and qualification status is maintained in a state of control. Recommend changes in policies and procedures to management to enhance the company's ability to conform to and maintain compliance with site, corporate, and regulatory standards. Lead cGMP master plans, process validation protocols and reports, data retrieval, compilation, and verification from a variety of compliant electronic systems. Support data entry and reporting for PPQ reports and client campaign summary reports. Support raw materials qualification plans and criticality assessments. Conduct departmental and site SOPs (Standard Operating Procedures) and PDs (Policy Documents). Support deliverables for Health Authority (HA) Inspections and specifically Pre-Approval Inspections (PAI) efforts.

Qualifications: Bachelor’s degree in Chemical Engineering, or related field of study and 3 years of experience in Validation Engineering, Validation Science or any combination thereof.

3 years of experience with each of the following:

1) GAMP and compliance requirements;

2) Laboratory systems with computer controlled functions and cleaning and sterilization process validation;

3) Environmental mapping requirements, mechanical equipment engineering and software functional testing;

4) Experience with safety factors related to facility and utility support equipment including HVAC, purified water, clean stream, and clean process air;

5) Unit operations process equipment and process support equipment, including sterilizers and washers;

6) Temperature mapping instrumentation, including Kaye Validators and data loggers;

7) Computerized work stations;

8) Regulatory guidance documents;

9) Generating concise procedures, protocols, and summary reports;

10) Applying validation principles; and

11) Equipment control software.

2 years of experience with each of the following:

• Applying mathematical concepts such as exponents, algorithms, quadratic equations, and permutations; and
• Applying mathematical operations to frequency distribution, variance analysis, and determination of reliability and validity.

Range: $94,000.00 / yr - $104, 000.00 / yr.

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.

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.