Durham, North Carolina, United States · On-site
JOB SUMMARY 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 ex…
Skills: Computer Systems Validation, CSV Lifecycle, 21CFR Part 11, EU Annex 11, Data Integrity
Durham, North Carolina, United States · On-site
About the Company: NIRSense is a cardiology company focused on developing world-leading non-invasive medical devices. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the…
Skills: Electrical Engineering, Low-noise Analog Design, Mixed-signal Design, PCB Design, Altium Designer
Durham, North Carolina, United States · On-site
Primary Function: Our Morrisville, NC location is seeking a Senior Software Engineer to strengthen in-house ownership of FloLogic’s cloud, web, and mobile platforms. This hands-on individual contributor role is cen…
Skills: C#, .NET, Azure, IoT, API development
Durham, North Carolina, United States · Remote OK
Summary The Energy Project Engineer III leads engineering work to develop and implement energy efficiency and energy production projects for customer facilities. Projects include energy efficiency upgrades, renewable ene…
Skills: Project management, Energy efficiency, Mechanical engineering, Electrical systems, HVAC design
Baltimore, Maryland, United States · On-site
$40/hr–$45/hr
EIS Holding, LLC, is one of the largest providers of turnkey environmental services in the country, providing soil and groundwater remediation, asbestos and lead abatement, demolition, mold remediation, and air duct clea…
Skills: UST installation, AST installation, System testing, Integrity assessments, Troubleshooting
Durham, North Carolina, United States · On-site
MACOM (NASDAQ: MTSI) is a global leader in the design and manufacture of advanced semiconductor products across a diverse range of end markets, including Data Centers, Telecommunications, Industrial and Aerospace and Def…
Skills: CVD, PVD, ALD, Semiconductor processing, Thin film deposition
Santa Clara, California, United States · On-site
$168k–$322k/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: C, Python, Linux, Networking, InfiniBand
Durham, North Carolina, United States · On-site
About Us We perform installation, rigging, millwrighting, and maintenance for manufacturing and industrial markets across the Southeast. Job Summary Southern Industrial Constructors, Inc. seeks a Pipefitter for a project…
Skills: Pipefitting, Rigging, Millwrighting, Pipe installation, Threading pipe
Durham, North Carolina, United States · On-site
About Us We perform installation, rigging, millwrighting, and maintenance for manufacturing and industrial markets across the Southeast. Job Summary Southern Industrial Constructors, Inc. seeks a Pipefitter Foreman for a…
Skills: Pipefitting, Rigging, Millwrighting, Hoisting equipment operation, Structural steel installation
Durham, North Carolina, United States · On-site
Description Phononic is the global leader in solid state cooling, a groundbreaking approach using the power of phonons to revolutionize how the world sustainably cools. The world’s most important technologies across supp…
Skills: Device assembly, Pick and place, CSAM, Automated inspection, Manual inspection
Durham, North Carolina, United States · Hybrid
$65k–$75k/yr
Fresh grad Electrical or Mechanical Engineer with exposure to HVAC, power tools, gardening tools, fans, water heaters, or similar product categories. Seeking candidates for an Engineer role in RTP, NC, with a hybrid sche…
Skills: Electrical engineering, Mechanical engineering, HVAC systems, Product testing, Product evaluation
Durham, North Carolina, United States · On-site
Summary Perform all inspections and functional testing on all manufactured generator systems to ensure that the gear meets necessary electrical code, that the gear functions as designed by the specified engineer, and tha…
Skills: Quality control, Electrical testing, Generator systems, Switchgear, NFPA70E
Durham, North Carolina, United States · Hybrid
$155k–$190k/yr
Company Overview: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with …
Skills: Training design, GMP compliance, GXP environment, Quality management systems, Instructional design
Durham, North Carolina, United States · On-site
JOB SUMMARY *Dayshift: 6AM-6PM, 2-2-3 rotating schedule The Senior Manufacturing Associate I/II (Days) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for…
Skills: Bioprocessing, Upstream processing, Downstream processing, GMP, Aseptic processing
Durham, North Carolina, United States · On-site
Job Description *Night Shift / 7PM -7AM / 2-2-3 schedule The Manufacturing Associate I/II (Nights) will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environ…
Skills: Bioprocessing, Upstream processing, Downstream processing, GMP, Aseptic processing
Durham, North Carolina, United States · On-site
This Opportunity WSP has an exciting career opportunity for a Construction Materials Testing Team Lead to join our Durham office. This individual will manage our construction materials inspection, testing and laboratory …
Skills: Construction materials testing, Team leadership, Project management, Business development, Strategic planning
Durham, North Carolina, United States · On-site
$20/hr–$23/hr
Who is a Manufacturing Technician at SMT? As a Manufacturing Technician, you will assist in the manufacturing of tracking technology and hardware from our Durham, NC manufacturing facility. This opportunity requires an e…
Skills: Manufacturing, Assembly, Machine maintenance, Safety regulations, Equipment operation
Durham, North Carolina, United States · Remote OK
Job Summary: The Field Application Engineer is responsible for driving adoption of the company’s products and services by influencing architects, engineers, and construction (AEC) firms at the design and specificat…
Skills: Microgrid, BESS, Distributed Energy Resources, Data Center, Engineering Design
Durham, North Carolina, United States · On-site
Amentum is seeking a 1st shift CNC Machine Repair Technician II to join our team 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 providin…
Skills: CNC machine repair, Troubleshooting, Preventive maintenance, Electrical control systems, Mechanical schematics
Waltham, Massachusetts, United States · Hybrid
$188k–$314k/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: Drug Design, Drug Development, Drug Discovery Process, Drug Discovery Research, Medication Safety
Durham, North Carolina, United States • On-site
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The specialist will manage the execution and documentation of the Computer Systems Validation (CSV) program at the Durham facility to ensure regulatory compliance. They will also collaborate on validation activities for lab and manufacturing systems while maintaining project deadlines and performance standards.
Candidates must hold a Bachelor's or Master's degree in Engineering or Information Technology with 5-7 years of industry experience. Proficiency in lab equipment validation, cGMP standards, and strong project management skills are required.
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.
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. (40%)
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. (30%)
Plan, contribute and collaborate on CSV activities for lab and manufacturing systems. (25%)
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. (5%)
Experience:
•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.
Language Ability:
Ability to read, analyze, and interpret complex documents. Conveys information clearly and concisely, both orally and in writing. 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. Interfaces professionally, effectively, and efficiently with all levels of management, coworkers, and outside vendors.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Understands implications of non-compliant results. Strong attention to detail. Ability to interpret an extensive variety of technical instructions and prioritize tasks accordingly.
Math Ability:
Strong math and analytical skills required. Ability to apply advanced mathematical concepts such as exponents and algorithms. Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.
Physical Demands:
Ability to walk and stand in order to perform and assist in performance of protocol execution and computer system evaluations. Ability to lift, carry, push and pull computer hardware when needed.
Computer Skills:
Web applications, spreadsheets, word processing, PowerPoint, and e-mail
Equipment Use:
Computer, telephone, copier/printer
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
Based on 336 listings with disclosed salaries, most engineering jobs in Durham, NC pay between $54k–$250k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 734 open engineering positions in Durham, NC listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include NVIDIA, Fidelity Investments, Hewlett Packard Enterprise, KBI Biopharma, Analog Devices, among others. Browse the listings above to see every active employer.
Yes — 211 of the 734 open engineering positions offer remote or hybrid work (61 remote, 150 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
