Durham, North Carolina, United States · On-site
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use. This will include auth…
Skills: Computer Systems Validation, GAMP, 21 CFR Part 11, EU Annex 11, Data Integrity
Durham, North Carolina, United States · On-site
$24/hr–$25/hr
Amentum is seeking a 1st shift CNC Machine Repair Technician II to join our team at in Durham, NC. Typical work hours are 6:30 AM - 3:00 PM; hours may vary based on business demand. This position is responsible for provi…
Skills: CNC Machine Repair, Preventive Maintenance, Electrical Troubleshooting, PLC Logic, VFD Troubleshooting
Rockville, Maryland, United States · Hybrid
$114k–$190k/yr
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicin…
Skills: CMC Regulatory Strategy, FDA Liaison, Biologics, eCTD Module 3, Lifecycle Management
Durham, North Carolina, United States · On-site
Position Summary The Embedded Systems Hardware Engineer designs, prototypes, tests, and troubleshoots embedded controller hardware used in industrial sensor products. This role works across the full lifecycle of embedded…
Skills: Embedded Hardware Design, PCB Layout, Schematic Capture, ESP32, Power Management
Durham, North Carolina, United States · On-site
ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaning…
Skills: Customer Service, Order Processing, Microsoft Excel, Windows 10, Chrome Browser
Durham, North Carolina, United States · On-site
Material Handler I, Distribution ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of peopl…
Skills: Inventory Management, Order Picking, Packing, Order Processing, Cycle Counting
Santa Clara, California, United States · Hybrid
$132k–$236k/yr
NVIDIA has been transforming computer graphics, PC gaming, and accelerated computing for more than 25 years. It’s a unique legacy of innovation that’s fueled by great technology—and amazing people. Today, we’re tapping i…
Skills: SRAM Layout, Custom IC Layout, Cadence Virtuoso, Physical Verification, Calibre
Durham, North Carolina, United States · On-site
$35/hr–$45/hr
Occupational Health Nurse Practitioner or PA - Business Health Solutions (BHS) Trust Your Gut. Take the Lead. Make a Difference. At Business Health Solutions (BHS), we don’t just react — we anticipate. We’re seeking an O…
Skills: Occupational Health Nursing, Clinical Assessment, Risk Recognition, Employee Education, Prevention and Intervention
Durham, North Carolina, United States · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven r…
Skills: Cell-based Potency Assays, ELISA, Real-time PCR, Enzymatic Activity Assays, Binding Kinetic Assays
Durham, North Carolina, United States · On-site
$18/hr–$20/hr
Description 3-D Print Specialist Explore the Future of Dental Technology at Absolute Dental Lab! Join Our Team of Artistic Technicians Are you passionate about digital technology and craftsmanship? Absolute Dental Lab, a…
Skills: 3-D Printing, Auto CAD, 3Shape, Preventative Maintenance, Troubleshooting
Durham, North Carolina, United States · On-site
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 t…
Skills: Data Analysis, Financial Forecasting, Capacity Modelling, Budget Management, Project Management
Durham, North Carolina, United States · On-site
JOB SUMMARY General responsibility for the installation, day-to-day 24/7 operation, maintenance, and modification of all KBI Biopharma site systems. This position is also responsible for repairs, troubleshooting, correct…
Skills: Corrective Maintenance, Preventative Maintenance, Troubleshooting, CMMS, Mechanical Systems
Durham, North Carolina, United States · On-site
Engineer/Scientist II, Drug Product Department: MS&T Employment Type: Full Time Location: Research Triangle Park, NC Description Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapi…
Skills: Drug Product Manufacturing, Aseptic Process Simulation, GMP Manufacturing, Tech Transfer, Process Validation
Durham, North Carolina, United States · On-site
Position Summary The R&D Engineer owns a wide range of hands-on hardware responsibilities — from sensor characterization and calibration, system validation to supplier quality and supporting new product development. This…
Skills: Sensor Calibration, Hardware Testing, Electronics Assembly, Technical Documentation, Soldering
Durham, North Carolina, United States · On-site
Description Welder - 1st Shift Durham, NC Description About the Company: CORMETECH, Inc. was founded in 1989 and provides environmental engineering solutions and services to the North American and world's power, marine, …
Skills: MIG Welding, Blueprint Reading, Structural Welding, Non-structural Welding, Hand Tools
Durham, North Carolina, United States · Hybrid
AURA Technologies, LLC (AURA) is an advanced research and development (R&D) company creating game-changing innovations for the US Department of Defense and the private sector in cutting-edge technology. If you are a smar…
Skills: Analog Design, Mixed-Signal Design, FPGA Development, Verilog, PCB Layout
Durham, North Carolina, United States · On-site
$83k–$107k/yr
Position Summary Responsible for creating, optimizing, developing, updating, and sustaining diagnostic assays and reagents in a regulated environment while driving innovative solutions. Design and develop new biomolecule…
Skills: Diagnostic Assay Development, Reagent Optimization, Biomolecule Design, Analytical Verification, Validation Documentation
Durham, North Carolina, United States · On-site
$55k–$70k/yr
Why RTI RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solution…
Skills: Pilot Plant Operations, Troubleshooting, Gas Chromatography, Process Analytical Instrumentation, Sample Collection
Durham, North Carolina, United States · On-site
Associate Director, Analytical Development- Separation Assays Department: Analytical Development Employment Type: Full Time Location: Research Triangle Park, NC Description Kriya is a biopharmaceutical company whose miss…
Skills: AAV Gene Therapy Vector Characterization, Method Development, HPLC, Capillary Electrophoresis, ELISA
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Support the full Computer Systems Validation (CSV) lifecycle by authoring protocols, test scripts, and summary reports to ensure systems remain in a qualified state. Maintain compliance with regulatory standards including 21 CFR Part 11 and EU Annex 11 while coordinating quality event processes like Change Controls and CAPAs.
Requires a Bachelor's degree in Engineering, IT, or a related field with 3-5 years of CSV experience in the pharmaceutical or biotechnology industry. Must have at least 3 years of hands-on experience with GAMP and 21 CFR Part 11 compliance.
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use. This will include authoring of protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for systems and re-qualifications.
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.
The role will also be generally responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests. In addition, there will be tasks related to coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.
Minimum Requirements:
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.
Science Driven. Customer Focused.
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. KBI is proud to be a JSR Life Sciences Company.
Offices: 4117 Emperor Blvd, Durham, North Carolina 27703, US · 1101 Hamlin Rd., Durham, NC 27704, US · 2500 Central Ave., Boulder, CO 80301, US · 1450 Infinite Drive., Louisville, CO 80027, US · 47 National Way, Durham, North Carolina 27703, US
There are currently 401 open manufacturing positions in Durham, NC listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include MSD, KBI Biopharma, RRD, Wolfspeed, PowerSecure, Inc., among others. Browse the listings above to see every active employer.
Yes — 49 of the 401 open manufacturing positions offer remote or hybrid work (7 remote, 42 hybrid).
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