KBI Biopharma
Sr. Computer Systems Validation Specialist
USA - NC - Durham - Hamlin Rd · Senior
Sponsorship not specifiedDetected 73 days ago
GCPProject ManagementGMPCommunicationMicrosoft OfficeVariance Analysis
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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
- Complete the execution and documentation of the CSV Program at the Durham facility.
Responsibilities
- Plan, contribute and collaborate on CSV activities for lab and manufacturing systems. (25%)
- 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.
Requirements
- 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.
- Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers in order to understand situations and to perform their assignments.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
Skills
- Web applications, spreadsheets, word processing, PowerPoint, and e-mail
- Computer, telephone, copier/printer
- KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
- 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.
- Equipment Use:
- Keep current of trends, new products and technologies, and regulatory requirements that may have an impact on CSV.
Benefits
- 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.
Company info
- 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.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.