Durham, North Carolina, United States · On-site
JOB SUMMARY The Manufacturing Execution System (MES) engineer on the MES operations team will support the startup and ongoing manufacturing operations at a biopharmaceutical manufacturing facility. The individual will re…
Skills: MES, MODA-ES, GMP, Technical writing, SQL
Durham, North Carolina, United States · On-site
Job Description: Note: Fidelity will not provide immigration sponsorship for this position. The Role Fidelity is building a modern, in-house Workforce Management (WFM) platform. You will own and build a constraint-solver…
Skills: Operations Research, OR-Tools, CP-SAT, Constraint Programming, Integer Programming
Durham, North Carolina, United States · On-site
$33/hr–$58/hr
Here at Amazon, we embrace our differences. We are committed to furthering our culture of diversity and inclusion of our teams within the organization. How do you get items to customers quickly, cost-effectively, and—mos…
Skills: Safety compliance, Risk assessment, Incident investigation, Auditing, Regulatory compliance
Durham, North Carolina, United States · On-site
$60k–$102k/yr
Durham County Government employs approximately 1,900 employees that work towards providing needed services throughout the community. With a wide array of services, Durham County Government is at the heart of a rapidly gr…
Skills: Radio systems maintenance, Troubleshooting, Technical support, Inventory management, System documentation
Durham, North Carolina, United States · On-site
Position Summary Quality Engineer II-III, Quality Assurance is responsible for designing, implementing, and maintaining the Quality Management System across the manufacturing lifecycle. This role supports process validat…
Skills: Quality Management Systems, GMP, GLP, Process Validation, CAPA
Wilmington, Massachusetts, United States · On-site
$22/hr–$41/hr
Are you a problem solver looking for a hands-on internship position with a market-leading company that will help develop your career and reward you intellectually and professionally? About Analog Devices Analog Devices, …
Skills: Analog circuits, RF circuits, Signals and systems, ADCs, DACs
San Jose, California, United States · On-site
$19/hr–$35/hr
Are you a problem solver looking for a hands-on internship position with a market-leading company that will help develop your career and reward you intellectually and professionally? About Analog Devices Analog Devices, …
Skills: Digital circuit design, Verilog, VHDL, RTL design, Verification
Durham, North Carolina, United States · On-site
Job Description At Wolfspeed, we do amazing things in a human way. We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate different perspectives …
Skills: Industrial water engineering, Wastewater treatment, System hardening, Root cause failure analysis, Project management
Durham, North Carolina, United States · On-site
Job Description: Note: Fidelity will not provide immigration sponsorship for this position. The Role Fidelity is building its next generation contact center platform to deliver highly reliable, intelligent, and scalable …
Skills: Kamailio, FreeSWITCH, SIP, Telephony, Voice platform architecture
Durham, North Carolina, United States · On-site
$26/hr–$43/hr
Join a skilled maintenance team responsible for keeping critical pneumatic transport systems operating efficiently and reliably. This is a 2nd Shift position. Be You. Independently perform complex technical tasks associa…
Skills: Pneumatic transport systems, Troubleshooting, Preventive maintenance, Technical repair, System installation
Colorado Springs, Colorado, United States · Remote OK
$121k–$284k/yr
Presales, Systems Engineer - SLED This role has been designated as ‘Remote/Teleworker’, which means you will primarily work from home. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing …
Skills: Networking, Presales, Consultative selling, SD-WAN, SASE
Durham, North Carolina, United States · On-site
$22/hr–$36/hr
Help to maintain and advance critical electronic systems while providing expert guidance in a fast-paced, mission-driven environment. Be You. Perform a variety of technical tasks in the construction, operation and mainte…
Skills: Electronics repair, Soldering, Circuit repair, Equipment calibration, Preventive maintenance
Santa Clara County, California, United States · On-site
$113k–$168k/yr
Job Summary Are you ready to elevate your career in software engineering? NetApp is seeking Software Engineers to join our team and contribute to the development and design of innovative features for our flagship storage…
Skills: C, C++, Unix, Linux, System Programming
Wilmington, Massachusetts, United States · On-site
$22/hr–$41/hr
Are you a problem solver looking for a hands-on internship position with a market-leading company that will help develop your career and reward you intellectually and professionally? About Analog Devices Analog Devices, …
Skills: Oscilloscopes, Multimeters, Power supplies, Embedded systems, Communication protocols
Durham, North Carolina, United States · Remote OK
Summary In the position of Project Development Engineer, the primary responsibility is to serve as the technical resource contact for the DI sales team in the pre-sale development of opportunity scope, costing, and appli…
Skills: Electrical engineering, Mechanical engineering, CAD, Project development, Estimating
Durham, North Carolina, United States · Remote OK
Summary In the position of Project Development Engineer, the primary responsibility is to serve as the technical resource contact for the DI sales team in the pre-sale development of opportunity scope, costing, and appli…
Skills: Electrical engineering, Mechanical engineering, CAD, Project development, Power systems
Durham, North Carolina, United States · On-site
$161k–$305k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Program management, Strategic planning, Cross-functional collaboration, GMP manufacturing, Supply chain management
Durham, North Carolina, United States · On-site
$147k–$210k/yr
Minimum qualifications: Bachelor's degree or equivalent practical experience. 2 years of experience working in C++, Python, Go, or a similar language. 2 years of experience with network architectures, protocols (e.g., TC…
Skills: C++, Python, Go, Network Architectures, TCP/IP
Durham, North Carolina, United States · On-site
$80k–$115k/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: Cell Therapy, Gene Therapy, GMP, cGMP, SOPs
Durham, North Carolina, United States · On-site
Do you have a passion for helping bring innovative medical devices and drug delivery products to market that improve patients’ lives? Gilero, a Sanner Group company, is seeking an experienced Field Sales Business D…
Skills: Business development, Sales pipeline management, Medical device industry, Contract manufacturing, Consultative selling
Durham, North Carolina, United States • On-site
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The MES Engineer will support the startup and ongoing operations of a biopharmaceutical facility by managing electronic manufacturing records and logbooks. They are responsible for ensuring system compliance, performing manufacturing investigations, and implementing corrective actions within a GMP environment.
Candidates must hold a B.A./B.S. in Life Sciences or Engineering and possess 4-8 years of relevant experience. Proficiency in MES software, GMP regulatory requirements, and technical documentation is essential for this role.
JOB SUMMARY
The Manufacturing Execution System (MES) engineer on the MES operations team will support the startup and ongoing manufacturing operations at a biopharmaceutical manufacturing facility. The individual will report to the Associate Director of MES Operations.
The individual will be responsible for being a MES system specialist for the site. The ideal candidate will have experience with pharmaceutical manufacturing execution and automation systems. Experience with MES software is required (MODA-ES is HIGHLY desired). Familiarity with SQL, typescript/javascript, and Excel Macros is desired. Relevant experience with Allen Bradley PLC’s, OSI PI Historian, SQL Server, and SAP 4/HANA is a plus. Additionally, experience in support or operations for the startup and ongoing operations for a commercial GMP mammalian cell culture facility is highly desired.
The engineer should possess proven technical writing and problem-solving skills and a drive for continuous improvement. Additionally, experience with manufacturing deviation, CAPAs, and change controls in a GMP manufacturing facility is desired.
From a technical perspective, the individual will be responsible for supporting system activities such as generating electronic logbooks and electronic manufacturing production records, authoring functional and design specifications, setting system standards, providing system training and expertise, and owning and managing system change controls and supporting upgrades.
From a compliance perspective, the individual will be responsible for providing technical input to thorough and robust manufacturing investigations, implement effective corrective/preventative actions, and support/manage manufacturing change controls. This will ensure Quality compliance and regulatory requirements are met for GMP production.
The individual is responsible for working cross-functionally with the manufacturing departments, QA, MS&T, engineering, supply chain, QC and other key departments to ensure MES manufacturing operations are successful, reliable and compliant. This requires a drive for continuous improvement, simplicity, and superior equipment and human performance.
Position Responsibilities:
· Generation and revision of system lifecycle documentation associated with electronic manufacturing records and logbooks such as Functional/Design/Configuration Specifications, process and data flow charts, supporting risk assessments, and supporting equipment and facility procedures for specific manufacturing process units, as needed.
· Generation and revision of electronic manufacturing records and electronic logbooks within the MES platform, including impact/coordination for associated interfaces and databases, as well as support for testing and qualification activities, as needed. Requires routine interface with Manufacturing/MS&T to develop electronic records in alignment with process requirements and specifications.
· Supports system ownership tasks such as performing change control assessments, ensuring appropriate system maintenance is setup and executed, and supporting vendor coordination for system support and upgrades. Manages assigned change controls to ensure system is maintained in a compliant manner.
· Technical input to manufacturing investigations, problem solving, and root cause analysis. Ownership for implementing identified process improvements, CAPAs, Change Controls, and Safety Improvements as it relates to MES/IT platform.
· Develop, maintain, and deliver training programs for system end-users and create comprehensive documentation for MES processes and procedures (Use, Navigation, Access, etc.).
· Experience with the Agile framework and/or Scrum process, such as a team member in an Agile setting, is preferred. Experience with JIRA or SNOW applications are a plus.
· Solid and thorough understanding of GMP applications and associated regulatory requirements (including 21 CFR Part 11, Data Integrity, etc.).
· Knowledge of the IT system development life cycle and software quality assurance in a regulated environment. Knowledge of general networking concepts and IT best practices.
· Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing.
· Ability to work both independently and with teams at various levels in the organization.
Position Requirements:
· B.A./B.S. in a Life Sciences or Engineering degree and/or 4-8 years relevant experience or equivalent education and/or experience.
· Previous experience as an MES Engineer or equivalent role is required.
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.
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Companies currently hiring include NVIDIA, Fidelity Investments, Hewlett Packard Enterprise, KBI Biopharma, PowerSecure, Inc., among others. Browse the listings above to see every active employer.
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