Computer System Validation Jobs in Cary, NC (NOW HIRING)

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
Join a highly technical analytical team in a dynamic work environment as a member of the Analytical, Formulation and Stability (AFS) department and participate in contracted client analytical programs for monoclonal antibodies, recombinant proteins, and peptides as an Electronic Laboratory Notebook (ELN) Administrator. The ELN Administrator would provide timely end user support/guidance/assistance in the ELN system, as well as build, modify, and maintain templates and other user-managed information, conduct user training for the system, and provide basic troubleshooting. Additionally, this position is a technical lead/subject-matter-expert for the ELN system, responsible for coordinating and collaborating with AFS department management, the ELN Product Owner, and IT on system improvement initiatives, system maintenance, as well as the implementation of system configuration updates and new releases.
Position Responsibilities:

• Provide technical and end user support to ensure efficient and trouble-free operation of the ELN system. Configure, deploy, and manage IDBS ELN templates and other user-managed information for efficient data recording and retrieval.
• Maintain a strong working relationship with internal AFS customers, other KBI site AFS departments, the ELN Product Owner, and IT to facilitate the implementation of new releases, configuration updates, or addition of new features, ensuring enhanced functionality and user experience based on business needs. Serve as the voice of customer for AFS ELN users, receiving and disseminating end-user feedback regarding the system to AFS management, the Product Owner and IT. Lead and/or participate in system improvement initiatives.
• Train team members on ELN usage and best practices
• Perform data analysis to extract meaningful insights from the ELN
• Support client/regulatory audits as necessary.
• Develop and maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to computer system validation and compliance.
• Able to react to change productively and handle other essential tasks as assigned.

Position Requirements:

• Bachelor's degree in computer science, pharmaceutical science, biology, chemistry, or other related science/IT.
• Minimum of seven years of experience working in the pharmaceutical industry. Must have experience working within an electronic laboratory notebook system in the pharmaceutical industry, preferably IDBS.
• Knowledge and understanding of common analytical laboratory processes and assays (e.g., chromatography, rDNA, etc.), as well as quality control measures in the laboratory. Experience in distilling complex procedures/assays into a standardized template. Capable of identifying key steps, variables, and parameters within experiments and translating this knowledge into clear, structured formats.
• Previous work in a regulated environment (FDA, EPA, etc.) is required.
• Advanced proficiency in electronic laboratory notebook systems, IDBS preferred.

Candidate must have:

• Proven ability to work independently and as a part of the team to resolve issues
• Strong decision making and problem-solving skills
• Demonstrated level of respect for individuals
• High level of integrity and personal responsibility
• Strong collaboration and team building skills; strong communication and interpersonal skills
• Strong orientation for quality and customer service

Salary Range: $84,000 - $115,500
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.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
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.