Scope will include supporting all aspects of the Computer Systems Validation (CSV) Lifecycle. Employee will complete the execution and documentation of the CSV Program at the Durham facility. Employee will execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies. Employee will track changes to the regulatory environment and implement processes and procedures enabling KBI to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.Position Summary
- 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.
- Oversee the development of CSV best practices and promulgation to site CSV employees to support the timely delivery of validated computer systems for internal clients.
- 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.
- BS or MS in an Engineering or Information Technology discipline
- 5-7 years of industry experience
- Lab equipment validation knowledge and experience is required.
- Experience with IT computer validation and alignment of IT validation with other validation requirements is required.
- Knowledge of biotech manufacturing obtained from cGMP facility
- Demonstrated project management ability with good written and oral communication skills is required.
$95K - $115K
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. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.
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.