Computer Systems Validation SpecialistKatalyst HealthCares & Life Sciences • Triangle, NC
Computer Systems Validation Specialist
Katalyst HealthCares & Life Sciences • Triangle, NC
30+ days ago
Job type
- Full-time
Job description
Roles & Responsibilities:
Roles & Responsibilities:
- Support implementation of a new MES for drug substance manufacturing operations.
- Contribute across multiple phases including electronic equipment tracking, electronic batch records, and release-by-exception functionalities.
- Support the Quality Engineering workstream to ensure the site is prepared to adopt and sustain MES capabilities within routine production.
- Review and support execution and documentation of the CSV Program in accordance with the full CSV lifecycle, Documentation requirements, Validation plans and risk assessments, Functional requirements, Configuration specifications, Testing activities, Change control documentation.
- Validation and compliance reviews.
- Ensure project deadlines and quality performance standards are met for all CSV-related activities.
- Maintain up-to-date knowledge of applicable regulatory requirements impacting CSV.
- Review and approve computer systems in the field, including manufacturing and automation systems.
- Partner with Automation Engineering and system owners to resolve deviations identified during testing.
- Provide timely responses to management and end users regarding project or system inquiries.
- Deliver frequent status updates on CSV activities and project progress.
- Collaborate with project teams, contractors, system owners, and site operations staff.
- Report key activities and issues to the Senior Manager of Quality Engineering.
- + years of MES experience (required).
- Prior experience with Syncade MES strongly preferred.
- Hands-on knowledge of CSV within GxP-regulated pharmaceutical manufacturing environments.
- Ability to work effectively in a fast-paced, open-office setting with frequent distractions.
- Strong communication skills and ability to work in a matrixed team environment.
- Ability to coordinate multiple priorities and meet established deadlines.
Create a job alert for this search
Computer Systems Validation Specialist • Triangle, NC
Similar jobs
The SAS programmer position (IT Analyst/Programmer III) within the Enterprise Data Office (EDO) at the UNC System Office writes SAS programs and uses other tools such as Tableau and Microsoft Offic...Show more
We require the skills of a Controls Test Engineer who is knowledgeable of PLC design and State Machine Controls Software.BD is one of the largest global medical technology companies in the world.Ad...Show more
Title: Senior Systems Admin - Z/OS.Role will be upgrading, 3rd party, Mainframe, patching, working w/ DBAs.If interested please send your updated resume to.If you know of anyone in your sphere of c...Show more
Revenue Integrity Coding Billing SpecialistUnder the direction of the Director of Revenue Integrity, the Revenue Integrity Coding Billing Specialist provides revenue cycle support services through ...Show more
This Jobot Job is hosted by: Adrionna Roy.Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.Salary: $140,000 - $140,000 per year.We are a tech-driven, nimble i...Show more
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems.Responsibilities include participation in system design, preparation of tes...Show more
The application window is expected to close on: 03/13/2026.Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received.Business Systems Analy...Show more
The Computerized Maintenance Management System(CMMS) Analyst will provide a wide variety of analytical, strategic and operational support to the Facilities Management Department (FMD) primarily foc...Show more
Customs and Border Protection Officer (CBPO) .Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of hig...Show more
We require the skills of a Controls Test Engineer who is knowledgeable of PLC design and State Machine Controls Software.BD is one of the largest global medical technology companies in the world.Ad...Show more
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.We leverage our proprietary computational ...Show more
Compensated Surrogacy Opportunity - Make a Life Changing Impact and Earn $60,000+.Newborn Advantage Surrogacy is seeking qualified women to become gestational surrogates and help intended parents g...Show more
Position Summary: The Associate Clinical Sales Specialist is specifically responsible for obtaining and maintaining expert knowledge of Stryker Joint Replacement product portfolio including the Mak...Show more
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.No matter where your talents lie, join us and disc...Show more
Competitive weekly pay (inquire for details) .AlliedTravelCareers is working with Lancesoft Inc.CT Tech in Chapel Hill, North Carolina, 27514!.We are currently seeking qualified candidates for CT T...Show more
Support the Department of Veterans Affairs (VA) Electronic Health Record Modernization Integration Office (EHRM-IO) program as a Clinical Solution Advisor (SA).Provide technical expertise using Ora...Show more
Senior Validation Engineer (CSV), Biotechnology - (JP15063).Only qualified candidates need apply.Standard Working Hours 8:00AM - 5:00PM.Senior Validation Engineer (CSV), Biotechnology.Primarily res...Show more
Occupational Summary The Computerized Maintenance Management System(CMMS) Analyst will provide a wide variety of analytical, strategic and operational support to the Facilities Management Departmen...Show more
SAS Programmer/Analyst
InsideHigherEd • Chapel Hill, North Carolina, United States
Full-time
Last updated: 30+ days ago • Promoted
Control Systems Engineer/Robotics Test Validation
Becton, Dickinson and Company • Durham, NC, United States
Full-time
Last updated: 3 days ago • Promoted
Senior Systems Admin - Z/OS
Two95 International Inc. • NC, US
Remote
Full-time
Quick Apply
Last updated: 30+ days ago
Revenue Integrity Coding and Billing Specialist- Remote
Guidehouse • Durham, NC, United States
Remote
Full-time
Last updated: 9 days ago • Promoted
Senior Systems Analyst
Jobot • Durham, NC, US
Full-time
Last updated: 14 days ago • Promoted
Validation Engineer Senior
Varite • Holly Springs, NC, United States
Full-time
Last updated: 3 days ago • Promoted
Business Systems Analyst (hybrid) 1450616
Cisco Systems, Inc. • Research Triangle Park, North Carolina, United States
Full-time
Last updated: 23 days ago • Promoted
CMMS (Computerized Maintenance Management System) Analyst
Duke Clinical Research Institute • Durham, North Carolina, United States
Full-time
Last updated: 24 days ago • Promoted
United States Customs and Border Protection Officer
U.S. Customs and Border Protection • Timberlake, NC, US
Full-time
Last updated: 30+ days ago • Promoted
Control Systems Engineer/Robotics Test Validation
Becton Dickinson & Company • Durham, NC, United States
Full-time
Last updated: 3 days ago • Promoted
Manager, QA Validation (Contractor)
Kriya Therapeutics • Research Triangle Park, NC, US
Full-time
Quick Apply
Last updated: 30+ days ago
Compensated Surrogacy Opportunity - Make a Life Changing Impact and Earn $60,000+
Newborn Advantage Surrogacy • Roxboro, NC, US
Full-time
Last updated: 24 days ago • Promoted
Associate Clinical Sales Specialist (A.CSS)
Crosslink • Timberlake, NC, United States
Full-time
Last updated: 4 days ago • Promoted
COMPLIANCE SPECIALIST
Dukehealth.org • Durham, NC, United States
Full-time
Last updated: 3 days ago • Promoted
Travel CT Tech in Chapel Hill, NC
AlliedTravelCareers • Chapel Hill, NC, US
Full-time +1
Last updated: 30+ days ago • Promoted
Clinical Solution Advisor
RIT Solutions, Inc. • Durham, NC, United States
Full-time
Last updated: 3 days ago • Promoted
Senior Validation Engineer (CSV), Biotechnology
3 Key Consulting • Holly Springs, NC, United States
Permanent
Last updated: 3 days ago • Promoted
CMMS (Computerized Maintenance Management System) Analyst
Duke University • Durham, NC, United States
Full-time
Last updated: 2 days ago • Promoted